Title: Director, Medical Writing

Location: Remote US

Job Description:

Remote

Immunovant, 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.

The Role:

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

o 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.

o 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.

o 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.

o Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.

o Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate.

o Read, write, and speak fluent English; excellent verbal and written communication skills.

Work Environment:

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

Salary range for posting

$220,000 - $230,000 USD

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.

Immunovant

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