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Minimum
$0k/year
๐Ÿ’ฐ 401(k)
๐ŸŒŽ Distributed team
โฐ Async
๐Ÿค“ Vision insurance
๐Ÿฆท Dental insurance
๐Ÿš‘ Medical insurance
๐Ÿ– Unlimited vacation
๐Ÿ– Paid time off
๐Ÿ“† 4 day workweek
๐Ÿ’ฐ 401k matching
๐Ÿ” Company retreats
๐Ÿฌ Coworking budget
๐Ÿ“š Learning budget
๐Ÿ’ช Free gym membership
๐Ÿง˜ Mental wellness budget
๐Ÿ–ฅ Home office budget
๐Ÿฅง Pay in crypto
๐Ÿฅธ Pseudonymous
๐Ÿ’ฐ Profit sharing
๐Ÿ’ฐ Equity compensation
โฌœ๏ธ No whiteboard interview
๐Ÿ‘€ No monitoring system
๐Ÿšซ No politics at work
๐ŸŽ… We hire old (and young)
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โ›ฐ๏ธ North America
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๐Ÿข IMVT Corporation Remove this filter
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IMVT Corporation


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $100k - $155k*

Director

 

Support

 

Growth

Travel

Manager

Management

Senior

Biotech

IMVT Corporation is hiring a
Remote Senior Director Program Management

\n \n\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. \n\n \n\nThe Role: \n\nImmunovant is seeking a highly skilled Project Manager to play a key role on a highly dynamic cross-functional team. In this role, you will be responsible for collaborating across many company workstreams, including strategic planning and for managing one of Immunovantโ€™s development pipeline programs heading into Ph 2 and Ph 3 development.  The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\n \n\nKey Responsibilities:  \n\n\n* Provide program level support to a therapeutic teamโ€™s Ph 2 and/or Ph3 program.\n\n* Maintain visibility across indications to identify synergies/impact across functional areas.\n\n* Align with the cross-functional leadership team to develop strategic plans for the program and detailed, integrated timelines.\n\n* Develop and maintain relationships across the cross functional areas that support the program.\n\n* Lead discussions, gain cross-functional alignment towards goals, and set priorities towards expediting the development and commercialization of key programs.\n\n* Propose and explore multiple scenarios and challenge the team to consider innovative approaches to achieve faster execution while maintaining high quality.\n\n* Lead cross-functional risk discussions, Develop and maintain risk registry, and develop/monitor actionable mitigation and contingency plans across all functions (ie:  clinical, non-clinical, CMC, regulatory).\n\n* Monitor and track progress against set goals for program delivery.\n\n* Lead decision making discussions, capture and document key decisions and escalate appropriately to bring resolution to open / pending decisions effectively and in a timely manner.\n\n* Develop and support strategic initiatives to meet overall corporate goals.\n\n* Maintain dashboard and provide status updates for regular portfolio meetings.\n\n\n\n\n \n\nRequirements:\n\n\n* 15+ years of experience at a life sciences, biotech, or pharmaceutical company in a project management role in a fast-paced, demanding environment\n\n* BA/BS in math, science or engineering; MBA or advanced degree preferred\n\n* Demonstrated experience with full drug development lifecycle at a program level leading teams to deliver across late phases of development from (Ph 2 - BLA - to commercialization). Recent experience with Ph 3 leading to submissions and launch highly desirable.\n\n* Demonstrated ability to manage cross functional teams and diverse sets of stakeholders\n\n* Multitasking ability to oversee a large Program with multiple projects and reach milestones on time and with quality\n\n* Strong project management skills with a proven track record of success, expertise with PPM tools (eg: MS project). PMP certification desirable\n\n* Strong written and oral communication skills with incredible attention to detail\n\n* Willingness to roll up your sleeves and get in the details of the program\n\n* Demonstrate strategic thinking with ability to develop solid executable tactical plans\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Desire to work in a fast-paced, innovative environment\n\n* Facilitate risk discussions and develop actionable mitigation and contingency plans.\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\n \n\nWork Environment:\n\n\n* The position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (10-20%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $265,000.00 - $280.000.00.\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Travel and Senior jobs that are similar:\n\n $100,000 — $155,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
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IMVT Corporation

 This job is getting a high amount of applications right now (11% of viewers clicked Apply)

๐ŸŒ Probably worldwide
๐Ÿ’ฐ $65k - $115k*

Manager

 

Accounting

 

Support

Software

Controller

Travel

Assistant

Financial

Finance

Senior

Operations

IMVT Corporation is hiring a
Remote Senior Accounting Manager

\nThe Role: \n\nWe are seeking a detail-oriented and experienced accounting senior manager to join our growing Immunovantโ€™s Accounting team. As Senior Accounting Manager, you will play a vital role in supporting the accounting close process and own specific areas of responsibility, ensuring that the accounting operations are running smoothly.  This role reports directly to the assistant controller and offers an excellent opportunity for a motivated individual to contribute to our Company's success. \n\nKey Responsibilities:โ€ฏ \n\n\nPerform general accounting functions and take ownership of various accounting areas. \n\nResponsible for maintaining SOX controls for areas of responsibility. \n\nSupport the internal and external reporting requirements to ensure timely and accurate financial reports for management, investors, and regulatory compliance. \n\nConduct financial analysis to identify and explain trends and variances. \n\nCollaborate with cross-functional teams to provide financial insights that support R&D and G&A activities. \n\nEnsure compliance with accounting standards, regulations, and tax requirements. \n\nAssists with the quarterly review and annual audits by independent auditors. \n\nContinuously identify opportunities to streamline processes and improve financial operations. \n\nSpecial projects as needed. \n\n\n\n\nRequirements:\n\n\nBachelor's degree in Accounting. \n\nCPA License preferred. \n\nMinimum of 7 years of progressive experience in finance and accounting roles, including few years in public accounting (big four). \n\nSolid understanding of GAAP, financial reporting, and regulatory compliance. \n\nProficiency in financial software and ERP systems; experience with NetSuite is required and Coupa is preferred. \n\nExperience with Power BI, Power Automate and Power Query is a plus. \n\nExcellent analytical and problem-solving skills. \n\nStrong communication and interpersonal abilities, with the aptitude to collaborate effectively across departments. \n\nHigh level of integrity, attention to detail, commitment to accuracy and ability to manage multiple priorities. \n\n\n\n\nWork Environment: \n\n\nRemote-based \n\nDynamic, interactive, fast-paced, and entrepreneurial environment \n\nDomestic or international travel are required (20%) \n\n\n\n\nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $150,000-165,000. \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Accounting, Travel, Finance and Senior jobs that are similar:\n\n $65,000 — $115,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
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When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $100k - $155k*

System

 

Support

 

Growth

Director

Travel

Leader

Management

Lead

Content

Senior

Operations

Operational

Health

Executive

IMVT Corporation is hiring a
Remote Vice President Regulatory Operational Excellence

\n \n\nOrganizational Overview:\n\nImmunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.\n\n \n\nThe Role:\n\nThis newly created role within the Regulatory Affairs organization is an exciting opportunity for a seasoned Regulatory Affairs professional to serve as a leader in the oversight and optimization of multiple groups within the Regulatory Affairs department.  The VP of Regulatory Affairs Operational Excellence reports to the Senior Vice President of Regulatory Affairs and will be responsible for overseeing the following Regulatory groups:\n\n\n* Regulatory Operations\n\n\n* Regulatory Operations is responsible for regulatory/submission coordination (incl, development of submission content plans and timelines), regulatory information management and regulatory submissions, business processes related to submission publishing standards and correspondence archival, and Veeva RIM utilization and RIM-SMART.\n\n\n\n\n\n* Regulatory Business Operations\n\n\n* Regulatory Business Operations is responsible for development of best practices for information sharing and document writing, vendor management (including regulatory consultants, subscriptions, and contract medical writers), assessment of new technologies to improve efficiency in end-to-end regulatory support of clinical development programs, and development/assessment of overall regulatory and medical writing department budgets.\n\n\n\n\n\n* Medical Writing\n\n\n* Immunovant Medical Writing is composed of both in-house and contract writers. The team is responsible for development of writing standards and best practices, writing of documents including briefing documents, clinical protocols, CTD modules, investigators brochures, clinical study reports, responses to Health Authority queries, etc.\n\n\n\n\n\n\n\n\nThe ideal candidate will have subject matter knowledge in the above Regulatory arenas. S/He should have a proven track record of managing multiple functions and people with the discretion to appropriately prioritize initiatives and needs of their teams, groups, and individuals in a fast-paced and dynamic environment.  This position will need to have strong relationships across all functions associated with document content writing, management, and retention requirements.  This position will drive operational transformation to accommodate near- and long-term corporate objectives that require Regulatory operational foresight.  S/He will review clinical/regulatory documents to support all phases of drug development by leading MW project management activities of an interdisciplinary team to ensure documents are strategic, high quality, and comply with internal and external standards.  S/He will delegate workplans for ongoing initiatives as appropriate, and provide leadership and strategic support for the team responsible for development and implementation.\n\n \n\nKey Responsibilities: \n\n\n* Manage for 3 to 6 Regulatory personnel, including the Senior Director heads of Regulatory Operations and Medical Writing, who will also have their own direct reports.\n\n* Manage budget for Medical Writing and Regulatory Affairs department\n\n* Manage short term and long term activities and initiatives of Regulatory Operations, Regulatory Business Operations, and Medical Writing while adapting to changing priorities of the company and overall portfolio of programs.\n\n* Development and rollout of document templates and writing standards to ensure compliance with regulations, GxP standards, and other internal/external guidelines.\n\n* Portfolio-level oversight to ensure key content messaging messaging in regulatory/clinical documents across 1401 and 1402 programs.\n\n* Drive organizational improvement by proactively communicating with Regulatory and cross-functional stakeholders to problem-solve and identify appropriate operating models for each of the relevant functions.\n\n* Serve as a conduit of information flow between Regulatory leadership and the functions overseen by this position. Identify opportunities for synergies across the Regulatory organization.\n\n* Present various topics and recommendations to Immunovant executive leadership.\n\n* Ensure teams are tracking towards timely completion of deliverables.\n\n* When necessary, serve as intermediary between vendors in support of Immunovant Regulatory staff.\n\n* Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.\n\n* Continually evaluate appropriateness and effectiveness of quality standards, templates, information technology platforms, and processes; identify opportunities for improvements.\n\n* Foster the growth and development and provide mentorship for the Regulatory Affairs team.\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelorโ€™s degree in a scientific discipline required; advanced degree highly desired\n\n* Minimum 12-15 years regulatory industry experience in biopharmaceuticals\n\n* Experience with Veeva and implementation of new processes within Veeva\n\n* Experience with management of a budget to facilitate fiscal planning and accountability of spending.\n\n* Hands-on or oversight experience with regulatory support of clinical trials; regulatory operations and submission management; and regulatory writing\n\n* Experience with clinical stage assets required; experience with BLA/MAA and post-marketing strongly preferred\n\n* Highly effective communication skills and confidence to lead strongly when necessary/appropriate\n\n* Ability to pivot comfortably and judiciously communicate change within a rapidly evolving company environment\n\n* Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.\n\n* Strong knowledge of eCTD elements and structure with regulatory writing skills\n\n* Strong knowledge of drug development, FDA, EMA and other guidelines and regulations\n\n* Working knowledge of electronic submission procedures and document management system requirements.\n\n* Working knowledge of regulatory submission management, electronic publishing, and document management. Experience with Veeva systems strongly preferred.\n\n* Experience of filing NDA/BLA/MAA application and meeting submission quality and standards\n\n* Demonstrated experience with effective management of direct reports, contractors/consultants, and vendors.\n\n\n\n\n \n\nWork Environment:\n\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Immunovantโ€™s headquarters is located in New York City. The position will be remote work.\n\n* Domestic travel required (up to 20%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $320,000.00 - $340,000.00.\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Travel and Senior jobs that are similar:\n\n $100,000 — $155,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $70k - $110k*

Manager

 

Design

 

System

Security

Architect

Technical

Support

Growth

Travel

Administrator

Admin

Management

Senior

Biotech

IMVT Corporation is hiring a
Remote Senior Manager IT Systems Admin

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role:\n\nImmunovant is seeking an experienced IT System Administrator and Architect for our Veeva platform. In this role you will partner with Veeva and the business stakeholders to design, develop, implement and support Veeva solutions aligned with the best practices. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Understand business requirements and convert them into functional and non-functional requirements\n\n* Lead end-to-end solutioning for Veeva platform in partnership with the business stake holders and third-party service providers. Configure and troubleshoot lifecycle, workflows, documents, and objects\n\n* Setup and manage document type tree/ hierarchies\n\n* Design and administer security roles including Dynamic Access Control (DAC) records as appropriate\n\n* Define and manage user access provisioning and de-provisioning for the Veeva platform\n\n* Manage Veeva platform and end-user licensing in partnership with the business/ functional stakeholders\n\n* Act as single point of contact for resolution of Veeva platform issues by coordinating with the business, IT Managed Services Provider (MSP), Veeva Application Management Services (AMS) and other third-party service providers\n\n* Analyze, implement, and document change and service requests.\n\n* Manage high priority requests and application downtime (planned & unplanned)\n\n* Ensure all Veeva modules remain fully validated during scheduled updates\n\n* Mentor and train functional area engagement teams on Veeva platform adoption.\n\n\n\n\nRequirements:\n\n\n* 7 to 10 years of experience at a life sciences, biotech, or pharmaceutical company providing business analysis and application implementation/ support in a fast-paced, demanding environment\n\n* Subject matter expertise in at least two Veeva Vault modules such as QualityDocs, RIM, eTMF, MedComms and PromoMats; experience in at least one of the regulated Veeva Vault modules a must.\n\n* Experience with Veeva CRM strongly preferred\n\n* At least two full life cycle Veeva Vault implementations\n\n* Certifications in Veeva Vault and Veeva CRM strongly preferred\n\n* Expertise in solution architecture design, technical integration design and Vault platform best practices\n\n* Thorough understanding of system validation and change management\n\n* BA/BS in Information Technology, business, or science\n\n* Strong attention to detail\n\n* Strong analytical, consulting, and problem-solving skills\n\n* Understanding of drug development from Phase 2 to launch\n\n* Multitasking ability to work on several projects\n\n* Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n* Experience in Start-ups a plus.\n\n* Excellent communication and interpersonal skills.\n\n* Ability to work collaboratively with cross-functional teams.\n\n* Strong analytical and problem-solving skills.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required 10%\n\n\n\n\n \nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $170,000.00 - $185,000.00.\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Travel and Senior jobs that are similar:\n\n $70,000 — $110,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $95k - $136k*

Support

 

Travel

 

Management

Operations

Healthcare

Non Tech

IMVT Corporation is hiring a
Remote Sr Clinical Trial Associate

\n \n\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. \n\n \n\nThe Role:\n\nImmunovant is seeking a Clinical Trial Associate to play a key role on a highly dynamic cross-functional team. You will be responsible for administrative support in the advancement of rare disease clinical trials as part of Immunovantโ€™s Clinical Operations team from study start-up to study closure.\n\n\nKey Responsibilities:\n\n\n* Develop clinical team meeting agendas, minutes, and track follow-up actions\n\n* Ensure inspection readiness of eTMF in conjunction with eTMF lead.\n\n* Maintain a vendor and site contact list\n\n* Provide study level requirements for insurance needs to central team\n\n* Provide review of regulatory submission and regulatory greenlight packages\n\n* Support CTM is data review activities.\n\n* Ensures access to systems for clinical team members\n\n* Administrative support for the clinical team\n\n* General support for inspectional readiness activities\n\n* Support planning activities for offsite study meetings and site visits\n\n\n\n\n\nRequirements:\n\n\n* BA/BS in a clinical or scientific discipline; at least 4 years of industry experience; working with a pharmaceutical / CRO or healthcare industry\n\n* Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus.\n\n* Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, and drug safety.\n\n* Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent.\n\n* Understanding of clinical trial operations and management of clinical trials at investigator sites\n\n* Multitasking ability to oversee a large number of projects and reach milestones on time\n\n* Exceptional academic and professional accomplishments, indicating critical thinking ability\n\n* Strong written and oral communication skills with incredible attention to detail\n\n* Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Desire to work in a fast-paced, innovative environment\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\n \n\nWork Environment:\nโ€ข Remote-based; Immunovantโ€™s headquarters is in NYC\nโ€ข Dynamic, interactive, fast-paced, and entrepreneurial environment\nโ€ข Domestic or international travel is required (10%)\n\n \nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $100,000.00 - $115,000.00.\n \n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Travel and Non Tech jobs that are similar:\n\n $95,000 — $136,250/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $60k - $100k*

Manager

 

Training

 

Support

Microsoft

Leader

Senior

Operations

IMVT Corporation is hiring a
Remote Medical Affairs Manager Field Operations

\n \n\nOrganizational Overview:\n\nImmunovanbt, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.\n\nThe role reports to Senior Director, Medical Affairs Operations and covers all indications.\n\n \n\nKey Responsibilities: \n\n\n* Updates MSL Training (SP and Veeva) program as required, additionally helps to schedule new MSL disease state training with TA leads\n\n* Provides first-line support for field systems (Veeva CRM, Vault Portal, ReadCube, etc.)\n\n* Supports Field Leadership with insight reporting โ€“ MSL team makes all entries, Ops Manager extracts data for leader to review, handles clean up and formatting to publish\n\n* Maintains tracker of MSL congress and regional meeting attendance and booth/table coverage to ensure appropriate staffing\n\n* Organizes regional meeting logistics and coordinates, with therapeutic area Sr. Director, MSL attendance and support at each meeting (conferences, ad boards, educ meetings)\n\n* Interfaces with Medical Communications to keep the MSL activities and coverage aligned\n\n* Provides support for formatting Post-Congress Summary Reports\n\n* Coordinates Veeva CRM activities across the MSL team and with SRM counterparts\n\n* Collects and readies field updates to publish in the twice-monthly digest (with our bulletin)\n\n* Liaises and coordinates information exchange and process updates between the US and EU team\n\n* Works with Medical Communications to determine ongoing needs for resources and with medical directors and MSL indication leads to develop, organize, and conduct training\n\n* Tracks and manages material inventory for the MSL team, ships replenishment or replacement material as needed\n\n* Identifies gaps and needs, raises with Ops leader to address\n\n* Keeps current the log of training activities for the field team\n\n* Executes periodic clean-up projects in CRM, field SP folders, and Veeva Vault\n\n* Responds to field requests for resources, assists with meeting coordination\n\n* Takes point on regular maintenance of systems, files, and processes the field team utilizes\n\n* Attends national congresses as needed to provide on-the-ground logistics\n\n* Supports one-time projects as needed\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelorโ€™s degree in general sciences\n\n* 3+ years experience supporting field resources, preferably medical field staff\n\n* Excellent critical thinking and process skills\n\n* Strong interpersonal and communication skills\n\n* Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.\n\n* Proven high attention to detail.\n\n* Demonstrated problem-solving skills \n\n\n\n\n \n\nWork Environment:\n\n\n* Remote based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n\n\n\n \n\nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $145,000.00 - $160,000.00.\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Microsoft and Senior jobs that are similar:\n\n $60,000 — $100,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $83k - $155k*

Director

 

Controller

 

Design

System

Support

Growth

Travel

Accounting

Financial

Senior

Operational

Biotech

IMVT Corporation is hiring a
Remote Senior Director Controller

\nThe Role:\n\nReporting to the VP Finance, this position is responsible for the controller group, producing accurate and timely financial statements, overseeing the close process and all other accounting responsibilities such as T&E, chart of accounts etc. The Controller will be the ultimate reviewer of the CRO and CMO accruals. This role requires strong managerial capabilities to drive process improvement, system implementations and employee development.\n\nKey Responsibilities: \n\n\n* Finalize accurate and timely monthly, quarterly and annual financial statements (balance sheet and statement of income) in accordance with GAAP. Design and manage the monthly close process to ensure timely and accurate financial statements.\n\n* Design, implement and maintain a system of internal controls to ensure safeguarding of Company assets and accurate financial statements.\n\n* Establish and enforce accounting policies and procedures and operational strategies including the review and implementation of process and system improvements.\n\n* Ultimate reviewer of CRO and CMO accruals, overseeing improvements to CRO and CMO accruals processes to support growth of the business.\n\n* Manage a team including multiple direct reports and a larger group of indirect reports ensuring appropriate allocation of responsibilities and sufficient back-up support.\n\n* Serving as principal contact with independent auditors.\n\n\n\n\nRequirements:\n\n\n* Bachelorโ€™s degree in accounting and Certified Public Accountant.\n\n* 15+ years of experience - some in public accounting (big four), at least 10 years of experience in the biotech industry and at least 6 years of experience as a controller.\n\n\n\n\n\n* Experience with financial reporting at a publicly traded company.\n\n* Experience with CRO and CMO +accruals is a must.\n\n* Demonstrated ability to organize an efficient and effective monthly closing process.\n\n* Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.\n\n* Team player, able to garner the respect of direct reports, peers, and superiors throughout the organization.\n\n* Strong communications and analytical skills.\n\n* Experience with NetSuite, Coupa, Expensify, Auxilius/Condor is preferred.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (20%)\n\n\n\n\n \n\nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $250,000.00 - $265,000.00.\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Travel, Accounting and Senior jobs that are similar:\n\n $82,500 — $155,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $70k - $165k*

Director

 

System

 

Training

Consulting

Support

Growth

Travel

Financial

Finance

Management

Lead

Operations

Operational

Legal

Biotech

IMVT Corporation is hiring a
Remote Director Clinical Procurement & Supplier Management

\n \n\nOrganization Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\nThis exciting, newly created role in Procurement will be responsible for leading the category management, sourcing, negotiations, and supplier management for all outsourced services related to the companyโ€™s clinical development pipeline and operations, while working cross functionally with internal stakeholders to ensure effective sourcing strategy, selection, contract negotiations, spend management, and resolution of supplier related issues. This leadership role requires keen business facing skillsets and acumen, as well as significant experience interfacing with, and managing, CROs and ancillary vendors across clinical development areas (e.g., Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Central Lab, TMF, etc.). Driving cross-functional collaboration with Immunovantโ€™s leadership, this role will lead procurement initiatives, requests for proposals, supplier selection, contract negotiations, and ongoing business oversight for new and existing vendors.\n\n \nKey Roles and Responsibilities:\n\nBusiness Partnership:\n\n\n* Interface with and facilitate (as needed) across Immunovantโ€™s functional areas to develop requirements and provide guidance/training to Business Owners (BOs) and stakeholders on the end-to-end sourcing process.\n\n* Partner early in cross-functional (Development, Legal, Finance, Program Management, etc.) business planning by effectively fostering relationships internally to maximize timely Procurement support for clinical programs, initiatives, and outcomes.\n\n* Establish clear external outcomes, deliverables/milestones, and payment structures within outsourced services and partners to effectively support the clinical programs and functions.\n\n* Ensure applicable vendors execute services as committed, and support issue resolution for clinical outsourced\n\n* Contribute and support the planning of clinical programs, supplier budgets, timelines, risk management, and financial implications for new or current programs.\n\n\n\n\n \n\nSourcing Process & Supplier Management Leadership:\n\n\n* Develop and execute sourcing strategies for outsourced services in the clinical pipeline.\n\n* Facilitate vendor selection across clinical development and operations teams (e.g. CROs and ancillary vendors).\n\n* Engage with BOs, stakeholders, vendors, and legal team to facilitate review of CDAs, CTAs, MSAs, Consulting Agreements, SOWs, Amendments/Change Orders, and other documents as required.\n\n* Lead the RFx and vendor bidding process for outsourced services, including RFP development, bid comparison analysis, bid defense meetings, and vendor scorecards, as well as manage any changes to existing programs (change orders, scope, etc.).\n\n* Manage the contracting process end-to-end working with key BOs, Legal, and Finance by optimal facilitation, review, and negotiations for outsourced services leveraging appropriate tools and guidance to support the functional areas.\n\n* Manage communication with outsourced vendors with respect to new and/or ongoing procurement support for programs, trials, etc.\n\n* Utilize expertise in total cost of ownership to facilitate and provide stellar negotiations leadership while focusing on โ€œwin-winโ€ solutions between Immunovant and outsourced partners.\n\n* Manage supplier enablement/onboarding and purchase orders in system of record.\n\n* Support or lead (as needed) supplier relationship management needs, including metrics/KPI development, scorecards, etc. for business review meetings with key partners.\n\n\n\n\n \n\nProcurement Operational Excellence:\n\n\n* Foster clear, consistent, and open collaboration internally and externally.\n\n* Identify and pursue continuous improvement and constructive change to support higher levels of procurement execution, including development of best practices and timely communication of key learnings.\n\n* Support the issue escalation process at the operational level and ensure timely escalation to senior\n\n* Collaborate with BOs, Legal, and Finance to drive the development of key document templates, training / awareness, negotiation / escalation parameters, processes, systems & tools to support Procurement growth and the clinical pipeline.\n\n* Collaborate with the Clinical and Quality organizations on developing updated procedures on selection, onboarding, and maintenance of outsourced partners.\n\n\n\n\n \nRequirements:\n\n\n* Bachelorโ€™s or Masterโ€™s degree with an emphasis on biotech/pharma, life sciences, outsourcing, supplier management, or business partnering.\n\n* 10+ yearsโ€™ experience in the pharmaceutical/biotech/CRO industry preferred, with a minimum of seven (7) years of direct end-to-end clinical outsourcing\n\n* Must have experience in the procure-to-pay (P2P) process and working in a P2P system. Coupa experience is a plus.\n\n* Excellent interpersonal skills and demonstrated ability to be independently business facing and influence across all levels.\n\n* Ability to build consensus and strong partnerships internally and externally. Must be highly team oriented and comfortable working with cross-functional teams.\n\n* Excellent analytical skills and effective written and verbal communication skills.\n\n* Experience working on clinical trials and working knowledge of GCP preferred.\n\n* Knowledge in clinical budgeting/forecasting and eRFx systems a plus.\n\n* People management experience highly desirable.\n\n* Demonstrated ability to drive oversight, performance and relationship management with CROs and other clinical service providers.\n\n* Highly skilled in establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and focus on delivery and commitments.\n\n* Excellent leadership and influencing skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.\n\n* Flexibility to adapt to the dynamic needs of a rapidly growing biotech company.\n\n* Strong understanding of the drug development lifecycle.\n\n\n\n\n \nWork Environment\n\n\n* Immunovantโ€™s headquarters is located in New York, New York. This position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment.\n\n* Domestic or international travel may be required (<10%).\n\n\n\n\n \n\n \n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Consulting, Travel, Finance and Legal jobs that are similar:\n\n $70,000 — $165,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $100k - $155k*

Director

 

Growth

 

Travel

Senior

Biotech

Health

IMVT Corporation is hiring a
Remote Associate Director Biostatistics

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role:\n\nReporting to the Senior Director, Biostatistics, this position is responsible for collaborating with both internal and external stakeholders to deliver the tactical execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans.\n\n* Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers.\n\n* Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory).\n\n* Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.\n\n* Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.\n\n* Oversight statistics and programming vendors.\n\n* Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.\n\n\n\n\nRequirements:\n\n\n* PhD or MS in Statistic, Biostatistics, Mathematics, or related field\n\n* 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area\n\n* Knowledge of relevant FDA, EU, ICH guidelines and regulations\n\n* Understanding of drug development\n\n* Demonstrated ability to collaborate with diverse sets of stakeholders\n\n* Strong written and oral communication skills with attention to detail\n\n* Desire to work in a fast-paced, innovative environment\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\nWork Environment:\n\n\n* Remote-based; access to Immunovantโ€™s NYC and North Carolina offices available\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment \n\n* Domestic or international travel may be required (~10%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Travel and Senior jobs that are similar:\n\n $100,000 — $155,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $95k - $138k*

Director

 

Technical

 

Software

Testing

Travel

Management

Operations

Biology

IMVT Corporation is hiring a
Remote Associate Director Analytical Sciences & Technology Bioassay

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role: The (Associate) Director, Analytical Sciences role is responsible for managing analytical development, method validation, and method transfer activities at contract testing laboratories for Immunovant Inc. The individual should be experienced in Bioassays and Molecular Biology methods for protein therapeutics and knowledgeable in biologics production, protein stability, statistics, and data management. Additionally, the role involves significant vendor oversight, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control.  The individual will oversee programs for reference materials, assay controls, critical reagents and laboratory cell banks.   The incumbent will work on setting of specifications, and trending of method performance for in-process, release, and stability testing and data. The individual is knowledgeable regarding regulations, industry guidances, and global quality systems for methods and stability, and will work closely with areas such as CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs to ensure deliverables coincide with process development and production schedules and regulatory submissions.\n\nKey Responsibilities: \n\n\n* Provide analytical oversight and approval of cGMP documents (method qualification and validation protocols and reports, technical reports, transfer protocols, justification of specifications, etc.)\n\n* Implementation and life-cycle management of methods for in-process, drug substance, and drug product samples as appropriate for clinical development and commercial phases\n\n* Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements\n\n* Ensure contracted third-party testing laboratories are in compliance with appropriate quality and regulatory practices to meet the desired quality attributes of Immunovant\n\n* Author relevant CMC sections for regulatory submission documents\n\n* Coordinate and/or participate in projects related to analytical responsibilities and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies\n\n* Establish current and long-range plans and objectives required to assure quality and regulatory compliance.\n\n* Monitor and assess emerging Quality and Regulatory requirements/issues and determines impact to Immunovant and works to remediate any identified gaps\n\n* Maintain an active analytical risk register compliant with current Quality Risk Management practices \n\n\n\n\nRequirements:\n\n\n* Bachelor of Science in an analytical field and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for Bioassays for development through commercial products; experience in biologics including monoclonal antibodies is highly preferred\n\n* Advanced knowledge in bioassays/molecular biology / microbiology method development, transfer, and validation activities are required. Demonstrated history of continuous improvement is desired\n\n* This role will involve oversight of method development and GMP testing at CMOs/ contract laboratories as it applies to laboratory and stability functions. Demonstrated experience effectively managing projects with contract testing laboratories is highly preferred\n\n* Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidances including ICH guidance documents is required, especially as pertain to product potency methodology.\n\n* Full understanding of GMPs and the pharmaceutical development process is required as well as transfer of processes and methods from development to clinical manufacturing to commercialization is necessary\n\n* Broad knowledge of risk-based Quality Systemsโ€™ components including Quality Risk Management is preferred\n\n* Knowledge of statistics including the use of JMP software is preferred\n\n* MS Office applications, Veeva QMS, Oracle, LIMS is highly preferred\n\n\n\n\nWork Environment:\n\n\n* Remote-based; will have access to Immunovantโ€™s NYC/NC offices\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (< 10%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Testing and Travel jobs that are similar:\n\n $95,000 — $137,500/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $95k - $138k*

Director

 

Software

 

Testing

Test

Travel

Management

Operations

IMVT Corporation is hiring a
Remote Associate Director Analytical Sciences & Technology

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role: The (Associate) Director, Analytical Sciences role is responsible for managing analytical development activities at contract testing laboratories for Immunovant Inc. This individual will work closely with other areas such as CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs to manage the method development, transfer, validation, and trending at testing laboratories to ensure timelines coincide with process development and production schedules. The individual should be knowledgeable in stability of biologics, statistics, and data management. Additionally, the role involves significant vendor oversight, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control. The incumbent will implement and oversee analytical strategies for drug product and device test methods, setting of specifications, and trending of method performance for release, and stability testing and data. The individual is knowledgeable regarding regulations, industry guidances, and global quality systems for methods and stability.\n\nKey Responsibilities: \n\n\n* Provides analytical oversight and approval of cGMP documents (change controls, deviations, CAPAs, method qualification and validation protocols and reports, transfer protocols, justification of specifications, etc.)\n\n* Implementation and life-cycle management of methods for testing raw materials, components, drug substance and drug product\n\n* Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements\n\n* Ensure contracted third-party testing laboratories are in compliance with appropriate quality and regulatory practices to meet the desired quality attributes of Immunovant\n\n* Author relevant CMC sections for regulatory submission documents\n\n* Coordinate and/or participate in projects related to analytical responsibilities and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies\n\n* Establish current and long-range plans and objectives required to assure quality and regulatory compliance.\n\n* Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant; work to remediate any identified gaps\n\n* Maintain an active analytical risk register compliant with current Quality Risk Management practices\n\n\n\n\nRequirements:\n\n\n* Bachelor of Science in an analytical field and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for development through commercial products; experience in biologics including monoclonal antibodies is highly preferred\n\n* Advanced knowledge in analytical and microbiology methods pertaining to drug product vial, syringe, device is highly preferred\n\n* Experience with development, transfer, and validation activities are required. Demonstrated history of methods continuous improvement is desired\n\n* This role will involve oversight of method development and GMP testing at CMOs/ contract test laboratories as it applies to laboratory and stability functions. Demonstrated experience effectively managing projects with contract testing laboratories is highly preferred\n\n* Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidances including ICH guidance documents, is required.\n\n* Full understanding of GMPs and the pharmaceutical development process is required, as well as transfer of processes and methods from development to clinical manufacturing to commercialization is necessary\n\n* Broad knowledge of risk-based Quality Systemsโ€™ components including Quality Risk Management is required\n\n* Knowledge of statistics including the use of JMP software is preferred\n\n* MS Office applications, Veeva QMS, Oracle, Empower, LIMS is highly preferred\n\n\n\n\nWork Environment:\n\n\n* Remote-based; will have access to Immunovantโ€™s NYC/NC offices\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (< 10%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Testing and Travel jobs that are similar:\n\n $95,000 — $137,500/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $60k - $110k*

Director

 

React

 

Technical

Support

Software

Microsoft

Leader

Management

Senior

Legal

Biotech

IMVT Corporation is hiring a
Remote Senior Director Associate General Counsel

\n \nCompany Description:\n\nImmunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compounds, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Both are optimized as a subcutaneous injection with potential flexibility in dosing and approach and are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.\n\n \n\nDue to our growth, we are seeking an Associate General Counsel to join the Immunovant legal department, occupying a position of significant responsibility and reporting directly to Immunovantโ€™s Chief Legal Officer. This individual will work cross-functionally and throughout the organization to provide a broad array of legal and compliance support. The attorney will support Immunovantโ€™s development programs and its multiple clinical trials, SEC filings, and provide counsel and guidance on privacy, business development/alliance management and strategic transactions. High-quality performance in this role will contribute meaningfully to Immunovantโ€™s overall success.\n\n \nKey Responsibilities:\n\n\n* Provide high quality legal advice and serve as a trusted strategic partner to a variety of internal teams\n\n* Coordinate transactional workflows to ensure consistent and efficient delivery of legal support\n\n* Draft and negotiate a broad range of agreements with a particular emphasis on clinical development agreements and related matters\n\n* Serve as a generalist on complex legal and compliance matters for Immunovant, adding legal and business value across all functional areas\n\n* Maintain frequent contact with all functions within the company while managing requests and prioritizing projects\n\n* Develop and present materials on relevant legal and business issues\n\n* Support business development, securities offerings, and other transactions\n\n\n\n\n \nRequirements:\n\n\n* Juris Doctor degree from an ABA-accredited law school and admission to at least one state bar\n\n* 10+ years of relevant experience including biotech/biopharma/pharma experience in an in-house setting and 15+ years of overall legal experience\n\n* Significant transactional experience and exemplary drafting and negotiating skills on a wide range of agreements\n\n* Excellent judgement and ability to asses risks and benefits and convey them in a clear and concise manner\n\n* Strong work ethic and ability to work independently, yet collaboratively, at all levels of the organization with minimal supervision\n\n* Self-motivated, self-starter, and independent\n\n* Excellent productivity, organizational, and time management abilities\n\n* Demonstrated ability to quickly grasp scientific and technical concepts\n\n* Agility and flexibility to handle multiple tasks in a fast-paced, dynamic, biotech environment\n\n* Effectively handle all job office equipment and software (including computer, Microsoft Office, SharePoint, and Slack)\n\n* Outstanding attention to detail and ability to react and respond quickly and effectively\n\n* Ability to exercise initiative and sound judgment and identify opportunities for improvement\n\n* Excellent written and verbal communication skills\n\n* Strong interpersonal skills\n\n* Creative problem solver and ability to think โ€œout of the boxโ€\n\n\n\n\n \nWork Environment:\n\n\n* The position is remote (work from home)\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Travel as required (<5%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $280,000.00 - $300,000.00.\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to React, Microsoft, Senior and Legal jobs that are similar:\n\n $60,000 — $110,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $30k - $50k*

Writer

 

Director

 

Travel

Manager

Strategy

Management

Lead

Junior

Operations

Non Tech

IMVT Corporation is hiring a
Remote Principal Medical Writer

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\nReporting to the Director, Medical Writing Operations & Regulatory Business Operations, this position is responsible for partnering cross-functionally to deliver high quality regulatory and clinical documents.\n\nKey Responsibilities: \n\n\n* Coordinate and author clinical and regulatory documents to ensure integration of scientific and medical input from development team members.\n\n* Lead submission-level documents at the project manager level and handle all components of writing clinical regulatory documents (e.g., Protocols, clinical study reports [CSRs], investigator brochures [IBs], etc.,).\n\n* Contribute to strategy from a medical writing perspective.\n\n* Assure documents are in accordance with the International Council for Harmonisation (ICH) and other regulatory guidelines.\n\n* Represent medical writing at cross-functional meetings (e.g., kick-off meetings [KOMs], comment resolution meetings, strategy discussions, etc.,) and provide information regarding requirements for medical writing deliverables.\n\n* Review protocols; amendments; statistical analysis plans (SAPs); table shells; tables, listings, and figures (TLFs), regulatory responses, and other regulatory documents to ensure consistency across all documents.\n\n* Raise any concerns regarding inconsistencies across documents or writers with the IMVT Director or Medical Writing to resolve and ensure consistency across both assets.\n\n* Arrange and lead team review meetings over the course of project progression.\n\n* Produce high-quality and timely documentation and provide input on data analysis, planning, and interpretation.\n\n* Maintain strict timelines as project lead.\n\n* Coordinate QC review of documents.\n\n* Mentor junior writers that are within the team.\n\n\n\n\n \n\nRequirements:\n\n \n\n\n* S./B.A. degree required, advanced degree highly desirable\n\n* Minimum of 5 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the ophthalmology or rare diseases therapeutic areas.\n\n* An understanding of the drug development process.\n\n* Experience in interacting with cross functional study team members Knowledge, Skills, and Abilities:\n\n\n\n\no Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing.\n\no Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details.\n\no Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.\n\no Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.\n\no Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate.\n\no Read, write, and speak fluent English; excellent verbal and written communication skills.\n\n \n\nWork Environment:\n\n \n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (10-20%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Non Tech and Non Tech jobs that are similar:\n\n $30,000 — $50,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $45k - $95k*

Director

 

Design

 

System

Technical

Support

Travel

Financial

Assembly

Leader

Strategy

Management

Senior

Operations

Executive

IMVT Corporation is hiring a
Remote Senior Director Clinical Supply Chain

\n\n\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role: \n\nThe Sr. Director, Clinical Supply Chain reports to the VP of CMC Operations & Global Supply Chain. The Sr, Director Clinical Supply Chain possesses a very good understanding of Clinical Supply Management and strategy, CMC regulatory, project management terminology and demonstrates effective communication skills.\n\nResponsible for leading and developing drug supply planning strategy and overall management of all aspects of drug supplies (IP) for global Phase I - III clinical studies as the leader across multiple IMVT studies. Communicate the supply strategies and supply needs back to CMC and develop am manufacturing strategy together with the technical team.\n\nImproves and/or stablishes operating policies and procedures and provide comprehensive coordination of complex global supply chain operations, inventories, materials, and procurement while ensuring compliance to regulations and guidelines.\n\nPerform financial planning for clinical supply management, including budgeting, forecasting, and strategic planning activities for clinical trials; and reconciliation of drug distribution invoices.  Mentors and manages direct reports supporting clinical trial supply managers and operations support.\n\nLead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management. Provide leadership and oversight in monitoring inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues. Provide Packaging and Labeling/distribution vendor oversight and relationship management.\n\nContribute and review the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinate the origination, proofing and translation of clinical study labels and generation.\n\nThe Sr. Director, Global supply chain, partners with the Clinical Operations group and CMC group to ensure continuous supply of Investigational Medicinal Product (IMP) for Immunovant trials. Support the development of packaging & labeling configuration, supports device assembly activities as they occur at packaging and labeling vendors, distribution and Interactive Response Technology (IRT) to supply study drug to global clinical trials using sound supply chain techniques.\n\nProvide leadership and management, and act as knowledgeable resource for establishment of effective collaboration with Clinical Operations for seamless delivery of IP to patients worldwide.\n\nProactively identifying potential issues, develop mitigating actions and notify Executive Management in a timely manner.\n\nProvide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs\n\n \n\nKey Responsibilities: \n\n\n* Interprets clinical synopsis and protocols and creates clinical forecasts.\n\n* Fundamental knowledge of inventory management and forecasting systems, IRT systems, and Clinical Trial Supply processes is required.\n\n* Oversee the execution of multiple clinical trials and proactively identifies potential supply chain issues, provides analysis and recommends solutions with the appropriate support from SMEs\n\n* Oversees and supports study close out activities including returned good reconciliation, inventory destruction Managing and executing overall Project Delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Regulatory, Clinical Development, and Clinical Operations).\n\n* Oversees the management of inventory and shipment logistics of all Immunovant product and potentially associated samples.\n\n* Ensures temperature excursion process is executed as required.\n\n* Liaison with Suppliers to manage relationships and drive triage level activities that require diligent focus with rapid start-up, resolution to issues, and respond to questions related to CMC projects.\n\n* Oversees and provides recommendations on packaging design based on study requirements, distribution and blinding strategy, oversees the execution of initial supplies and resupplies for all IMVT studies. Designs and implements strategic plans to supply study drug to complex global clinical trials using sound supply chain techniques.\n\n* Guides the IRT System Leads as necessary with regards to user requirement specifications management module(s) as applicable\n\n* Reviews IRT strategy across IMVT studies to ensure consistency where applicable\n\n* Leverages the inventory management capabilities of the IRT to appropriately manage studies\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelor's degree in science, engineering, or another relevant field; advanced degree preferred\n\n* Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development (pre-filled syringe), analytical development, and device development\n\n* 10-plus years of relevant biopharmaceutical industry experience with 8 plus years in clinical supply management\n\n* Deep understanding of IRT systems\n\n* Extensive experience with clinical study design, execution of clinical trials and investigational supply management\n\n* Ability to manage diverse project activities with global contract CMOs and create a collaborative environment\n\n* Strong computer skills including MS Office\n\n* Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results\n\n* Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Desire to work in a fast-paced, innovative environment\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\n \n\nWork Environment:\n\n\n* Immunovantโ€™ s headquarters is located in New York City. The position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (10-20%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n $45,000 — $95,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $60k - $110k

Director

 

Security

 

Technical

Travel

Operational

Health

IMVT Corporation is hiring a
Remote IT Director Digital Solutions

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role: \n\nAs the IT Director Digital Solutions your role is to partner with our Clinical Team leads to seek out trial appropriate digital solutions including eCOA, eConsent, telemedicine devices and other digital solutions, and in partnership with vendors and clinical trial teams, own the successful delivery of these.  This highly skilled and motivated individual, with experience in GDPR (General Data Protection Regulation) and data security, will play a crucial role in ensuring the secure and compliant integration of these digital solutions into our clinical trials.\n\n\n\nKey Responsibilities: \n\n\n* In close partnership with Clinical Trial teams, advise teams on most appropriate digital solutions and systems.\n\n* Lead the selection and the onboarding of the digital solutions vendor\n\n* Direct the technical and operational aspects of the digital solution implementation.\n\n* Ensure accurate programming, accountability, and reporting of digital solutions.\n\n* Oversee and manage digital solutions vendors.\n\n* Facilitate team meetings, cross-functional communication, and decision-making; ensure alignment with internal and external stakeholders.\n\n* Identify critical project risk factors and mitigating actions.\n\n* Ensure all solutions are compliant with Health Authority Regulations.\n\n* Partner with Immunovant cybersecurity to ensure that systems and devices keep our data secure.\n\n* Partner with DPO ensure that all PII collected is processed in a way that aligns to global data privacy laws.\n\n* Stay informed of the clinical digital solutions environment.\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelor's or Masterโ€™s degree\n\n* PMP certification\n\n* Solid knowledge of Health Authority requirements for use of Digital Solutions\n\n* Excellent understanding of digital solutions business practices and the current competitive landscape.\n\n* 7-10 years of experience working with clinical trial digital solutions and systems.\n\n* Strong understanding of clinical trials, device standards, and data security requirements.\n\n* Experience in Start-ups a plus\n\n* Excellent communication and interpersonal skills.\n\n* Ability to work collaboratively with cross-functional teams.\n\n* Strong analytical and problem-solving skills.\n\n\n\n\n \n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required 10%\n\n\n\n\n 
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $50k - $80k*

Manager

 

Design

 

System

Technical

Testing

Travel

Quality Assurance

Assembly

Management

Lead

Senior

Health

IMVT Corporation is hiring a
Remote Senior Manager CMC Quality Assurance

\nOrganizational Overview:\n\n \n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\n \n\nReporting to the Director, CMC Quality Assurance, this position is responsible for performing the primary Quality review of all post- manufacturing-related documentation for a large molecule - drug substance and sterile drug product. The CMC Quality Sr. Manager will be responsible for implementing processes for document receipt from contract manufacturing organization, batch packet assembly and transfer to internal Immunovant collaboration, quality review of manufacturing documents, and final submission into the electronic records retention system in compliance with global GxP regulations. This individual will have the unique opportunity to help design and shape IMVT Quality processes while collaborating with external contract organizations to establish compliant, efficient, measured, and integrated batch review processes at a rapidly growing biotechnology company.\n\n \n\nThe CMC Quality Sr. Manager assembles and performs a technical quality review of executed manufacturing and testing documents provided by the contract manufacturer and laboratories to ensure regulatory compliance with FDA, EMA, ROW and other applicable global health authority requirements that ultimately ensure patient safety. The CMC Quality Sr. Manager then will liaise with the Immunovant CMC Team and collaborate with the CMO Quality Unit to ensure prompt and thorough resolution to any open matters identified in the technical review.\n\n \n\nThis position will contribute to Immunovant's success by managing IMVT's batch compilation and review activities under the primary QA Leads' guidance while working closely with applicable functional areas across Immunovant and in partnership with CMO Quality.\n\n \n\nKey Responsibilities:\n\n \n\n\n* Provide strategic planning input and continual improvement measures focused on records processes or document structure, reporting/escalating critical quality issues\n\n* Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality through effective management with strong adherence to Immunovantโ€™s key value pillars\n\n* In close collaboration with the Quality and CMC, serve as a primary batch compilation lead and record point of contact for CMC and Quality, ensuring overall control and compliance, effectiveness, and efficiency of the Batch Compilation and Review Process\n\n* Partner with QA Document Control and Records Retention to define, develop, and document processes related to the assembly of the batch records in the eDMS system\n\n* Manage, maintain, and continuously improve the batch record review process as a facilitator for Quality Assurance in product teams\n\n* Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to Quality and error reduction. Encourage an environment for โ€˜Quality Right First Timeโ€™ by building in efficiencies as necessary from a systematic and compliance perspective\n\n* Perform additional quality-related duties as assigned by Director, CMC Quality Assurance\n\n\n\n\nRequirements:\n\n \n\n\n* Bachelor (B.S.) or advanced degree in Biology, Chemistry, Immunology or related fields\n\n* A minimum of 5-8 years of GMP-regulated experience working within GMP Quality systems; in roles of increasing responsibility; substantial Drug Substance and Drug Product, clinical & commercial experience in GMP environment preferred\n\n* Experience interacting with FDA, EMA, and other global health authorities\n\n* Strong analytical and organizational skills, with attention to detail\n\n* Excellent written, verbal, listening, and interpersonal communication skills\n\n* Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)\n\n* Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment\n\n* Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times\n\n\n\n\n \n\nWork Environment\n\n \n\n\n* Remote location\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic and international travel may be required (up to 10%) including required quarterly onsite meeting\n\n\n\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Testing and Senior jobs that are similar:\n\n $50,000 — $80,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $35k - $65k*

Director

 

Support

 

Travel

Content

Senior

Operations

Health

Non Tech

IMVT Corporation is hiring a
Remote Director Packaging and Distribution Quality

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role:\n\nImmunovant is seeking a Director, Packaging and Distribution Quality with experience in clinical and commercial packaging, labeling, and distribution (domestic and globally). This individual will work closely with our Contract Development and Manufacturing Organizations (CDMOs) and internal CMC Supply Chain team to oversee and manage the distribution of investigational materials for our ongoing clinical trials.\n\nThis position will contribute to Immunovantโ€™s success by overseeing the packaging and distribution of clinical materials under the guidance of the Sr. Director, CMC & Distribution Quality, while working closely with internal functions at Immunovant and external strategic partners.\n\nThe Director, Packaging and Distribution Quality will provide oversight and direction for Immunovantโ€™s supply chain operations to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. This position will apply knowledge of global regulations to assist in the creation and approval of clinical packaging and labeling materials. This candidate will also need to demonstrate the ability to support strategic plans for pack/label activities across multiple clinical programs, establish and maintain Quality Agreements, support deviations and CAPAs, manage complex change controls, and identify and mitigate inspection risks. In addition, this individual provides expertise to partner both internally and externally to drive continuous process improvement and mitigation activities pertaining to the distribution of investigational materials for clinical trials. This individual will perform all of these activities all while ensuring a culture of quality and compliance through effective leadership and strong adherence to Immunovant core values.\n\nKey Responsibilities:\n\n\n* Provides Quality oversight/support for pack/label activities across multiple clinical programs\n\n* Perform thorough review and approval of batch production records and creation of batch disposition packets.\n\n* Support the review of clinical and commercial label text, label proofs, and label specifications\n\n* Reviews and approves deviations at CDMOs to assess product quality impact. Monitor effectiveness checks of CAPAs\n\n* Assess product complaints and counterfeit claims\n\n* Perform assessments for change controls and performs final Quality approval\n\n* Supports the generation of risk assessments for distribution and packaging/labeling processes\n\n* Supports shipping qualification/validation studies\n\n* Supports the review of distribution protocols for Contract Distributors\n\n* Contribute to regulatory filing content related to combination products (IND, NDA, etc.)\n\n* May assist in the auditing of contract packaging / labeling sites and distribution centers.  \n\n* Effectively communicate ideas, project goals, and results to team members across functions and departments\n\n* May include oversight and mentoring of quality associates, fostering a collaborative and innovative working environment\n\n* Perform additional quality-related duties as assigned by Senior Director, CMC and Quality Distribution\n\n\n\n\nRequirements:\n\n\n* Bachelor (B.S.) or advanced degree; preferably in Biology, Chemistry, Engineering, or related fields\n\n* A minimum of eight (8) years of GMP experience with a focus on Quality Assurance (QA)\n\n* A minimum of five (5) years in roles of increasing responsibility in a biopharmaceutical environment\n\n* Experience interacting with FDA, EMA, and other global health authorities\n\n* Strong analytical and organizational skills, with attention to detail\n\n* Excellent written, verbal, listening, and interpersonal communication skills\n\n* Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)\n\n* Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment\n\n* Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times\n\n\n\n\nWork Environment:\n\n\n* Remote location\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic and international travel may be required (up to 10%) including required quarterly onsite meetings\n\n\n\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Non Tech jobs that are similar:\n\n $35,000 — $65,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $40k - $80k*

Director

 

Support

 

Travel

Strategy

Lead

Senior

Marketing

Excel

Non Tech

IMVT Corporation is hiring a
Remote Senior Director Marketing Endocrinology TA Lead

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\nReporting to the Vice President, Marketing, this position is responsible for the development and execution of a coordinated commercial therapeutic area strategy across customer groups. The Endocrinology TA Lead will work collaboratively with internal and external stakeholders to develop best-in-class brands spanning multiple potential indications, responsible for driving launch readiness and market success.\n\n \n\nKey Responsibilities: \n\n\n* Cultivate deep understanding of customer and competitor insights, market dynamics, and unmet needs\n\n* Develop deep working relationships with external thought leaders\n\n* Provide commercial leadership while collaborating closely with internal teams on cross-functional product development initiatives\n\n* Collaborate with other TA teams and functions towards developing and executing commercialization plans in Endocrinology\n\n* Lead the development and implementation of patient, provider and payer customer strategies\n\n* Execute initiatives that support disease state awareness and education; including collaborations with patient and professional advocacy\n\n* Manage team budget and resource requirements\n\n\n\n\n \n\nRequirements:\n\n\n* S./B.A. degree required, MBA and/or other relevant graduate degree highly desirable\n\n* 7 years of pharmaceutical marketing experience, including global and US\n\n* Minimum of 10 years related business experience in pharma/biotech\n\n* In-line marketing experience, professional, patient, and consumer\n\n* Previous field experience; focus in Endocrinology preferred\n\n* Demonstrated success in commercial leadership responsibilities, including both pre-launch and launch experiences\n\n* Proficient in strategies to facilitate US and global market access\n\n* Ability to integrate commercial, financial, and clinical perspectives to develop compelling brand strategies and tactics\n\n* Excellent written and verbal communication skills; highly proficient with MS Excel and PowerPoint\n\n* Proven track record of delivering creative solutions and driving high quality results as a team member and cross-functional leader\n\n\n\n\n \n\nWork Environment:\n\n\n* Remote-based\n\n* Willing to travel as needed to office headquarters in New York City\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (20%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior, Marketing and Non Tech jobs that are similar:\n\n $40,000 — $80,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $45k - $80k*

Manager

 

Design

 

Technical

Support

Software

Travel

Video

Cloud

Strategy

Senior

Operations

IMVT Corporation is hiring a
Remote Manager Senior Manager IT Operations

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role: \n\nAs a Manager/Senior Manager, IT Operations you will be a core member of the IT team and deliver across IT Operations. In this role, you will support the current install base with a strong focus on the customer. The successful candidate will have previously had roles in IT Operations supporting and delivering on a broad list of enterprise initiatives. Strong communication style and proven success managing a wide variety of priorities. Equally important to success is the ability to build relationships across the organization and to seek ways to support the enterprise IT objectives.\n\n\n\nKey Responsibilities: \n\n\n* Partner with others in IT to ensure a high level of customer fist support is delivered in a timely fashion.\n\n* Support the execution of the IT operations strategy aligned with the overall business goals.\n\n* Support the design, implementation, and maintenance of the organization's IT infrastructure.\n\n* Partner with MSP in support of Office 365, Azure and cloud environments.\n\n* Partner with MSP in support of office and remote network and infrastructure.\n\n* Partner with MSP in support of all Immunovantโ€™s end points.\n\n* Troubleshoot hardware and software issues related to internal IT systems.\n\n* Support IT projects, including the design and deployment of new IT systems and services.\n\n* Support the development of IT Policies and processes.\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related field or equivalent relevant experience.\n\n* 2-5 years of experience working in IT operations at a life sciences, biotech, or pharmaceutical company providing hands on technical support to a broad range of functions.\n\n* Strong desire to please the customer.\n\n* Working knowledge of computer systems, security, network and systems administration, databases and data storage systems, and video conferencing systems (Zoom).\n\n* Strong critical thinking and decision-making skills.\n\n\n\n\n \n\nWork Environment:\n\n\n* Preferred location is near Immunovantโ€™s NYC or Durham, North Carolina office.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment.\n\n* Domestic or international travel are required 10%.\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Video, Cloud and Senior jobs that are similar:\n\n $45,000 — $80,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $50k - $110k*

Director

 

Design

 

Security

Training

Travel

Strategy

Lead

Operations

IMVT Corporation is hiring a
Remote Director Cybersecurity

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role: \n\nAs a Director of Cybersecurity, you will be responsible for managing all aspects of an organization's cybersecurity strategy and operations. You will play a critical role in protecting the organization's information systems, networks, and data from potential cyber threats. The Director of Cybersecurity will work closely with leadership, IT teams, and other stakeholders to develop and implement robust cybersecurity policies, procedures, and technologies.\n\n\n\nKey Responsibilities: \n\n\n* Provide input to develop a comprehensive cybersecurity strategy aligned with the organization's overall business goals.\n\n* Implement cybersecurity strategy.\n\n* Partner with cybersecurity firm to conduct risk assessments and vulnerability analyses to identify potential threats and weaknesses.\n\n* Stay abreast of emerging cybersecurity trends and technologies to ensure the organization's defenses are up-to-date.\n\n* Maintain and update as necessary cybersecurity policies and procedures to safeguard the organization's assets.\n\n* Ensure compliance with relevant regulations and standards, such as GDPR, NIS2, HIPAA, ISO 27001, etc.\n\n* Maintain an incident response plan to effectively address and mitigate cybersecurity incidents.\n\n* Lead incident response teams in investigating and responding to security breaches or incidents.\n\n* Implement ongoing cybersecurity awareness programs for employees to promote a culture of security.\n\n* Conduct regular training sessions to educate staff on cybersecurity best practices and threats.\n\n* Partner with IT Operations lead and vendors to oversee the design and implementation of a secure IT architecture.\n\n* Evaluate and recommend cybersecurity technologies, tools, and solutions.\n\n* Collaborate with IT team to ensure the effective deployment and maintenance of security technologies.\n\n* Assess and manage cybersecurity risks associated with vendors and third-party relationships.\n\n* Ensure third-party security assessments are conducted regularly.\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelor's or Masterโ€™s degree in Cybersecurity, Information Technology, Information Systems, or a related field\n\n* Relevant certifications such as CISSP, CISM, or CISA\n\n* 5-7 years of experience working in Cybersecurity ensuring confidentiality, integrity, and availability of organization's data, preferably at a biotech, or pharmaceutical company\n\n* Strong understanding of cybersecurity frameworks, standards, and best practices.\n\n* Experience in Start-ups a plus\n\n* Excellent communication and interpersonal skills.\n\n* Ability to work collaboratively with cross-functional teams.\n\n* Strong analytical and problem-solving skills.\n\n* Experience in Cyber Security ensuring confidentiality, integrity, and availability of organization's data.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required 10%\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Design jobs that are similar:\n\n $50,000 — $110,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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