Medical Writing Director

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as a Medical Writer reporting to the Head of Medical Writing Operations & Regulatory Business Operations. You will partner cross-functionally to deliver high-quality regulatory and clinical documents, leading submission-level documents and ensuring compliance with ICH and other guidelines. Responsibilities include authoring various documents (protocols, CSRs, IBs, etc.), reviewing documents for consistency, representing medical writing at cross-functional meetings, and mentoring junior writers. The role requires a minimum of 12 years of relevant experience in the pharmaceutical industry, particularly in ophthalmology or rare diseases. A remote work environment is offered, along with a competitive salary, equity, and a comprehensive benefits package including unlimited paid time off and parental leave.

Requirements

• S./B.A. degree required, advanced degree highly desirable
• Minimum of 12 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the ophthalmology or rare diseases therapeutic areas
• An understanding of the drug development process
• Strong leadership skills
• Mentorship skills to train early career writers
• Experience managing direct and indirect reports, including medical writing contractors
• Experience in interacting with cross functional study team members
• 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
• 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
• 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
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
• Read, write, and speak fluent English; excellent verbal and written communication skills

Responsibilities

• Coordinate and author clinical and regulatory documents to ensure integration of scientific and medical input from development team members
• 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.,)
• Evaluate the consistency of style guide, scientific technical aspects and consistency of messaging across therapeutic area documents
• Contribute to strategy from a medical writing perspective
• Assure documents are in accordance with the International Council for Harmonisation (ICH) and other regulatory guidelines
• 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
• 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
• Raise any concerns regarding inconsistencies across documents or writers with the IMVT Director or Medical Writing to resolve and ensure consistency across both assets
• Arrange and lead team review meetings over the course of project progression
• Produce high-quality and timely documentation and provide input on data analysis, planning, and interpretation
• Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
• Ensure continuous awareness of the medical writing activities, plans, scope(s) of work and ways of working across the organization
• Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents

Benefits

• Remote-based
• Salary range for posting $200,000 — $230,000 USD
• Equity and other forms of compensation may be provided as part of a total compensation package
• Full range of medical, dental, vision, 401k, and other benefits
• Unlimited paid time off
• Parental leave