Director, Medical Writing

Reporting to: Head of Medical Writing Operations & Regulatory Business Operations

Location: Remote

Organizational Overview:

Immunovant, 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.

The Role:

This position is responsible for partnering cross-functionally to deliver high-quality regulatory and clinical documents.

Key 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.

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.

Knowledge, Skills, and Abilities:

• 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.

Additional Information:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity 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 $200,000 - $230,000.

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