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
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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