Director, Medical Writing

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%)