Intel Corporation is hiring a
Director, Medical Writing in Worldwide

Summary

The job is for a Director of Medical Writing at Immunovant, Inc., a clinical-stage immunology company specializing in anti-FcRn technology. The role involves cross-functional partnership to deliver high-quality regulatory and clinical documents for autoimmune diseases. The position is remote.

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

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