Senior Director Medical Writing Job at Meet Life Sciences in Chicago

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This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range $220,000.00 / yr - $275,000.00 / yr

Director / Senior Director, Medical Writing

Position Summary :

Reporting to the Vice President of Regulatory Affairs and Medical Writing, the Director / Senior Director will lead and manage the medical writing function. This individual is responsible for the development of high-quality clinical and regulatory documents, ensuring they meet global standards. The role involves close collaboration with cross-functional teams including Clinical, Medical Affairs, CMC, Regulatory, and Quality.

Key Responsibilities :

Lead the planning, development, and finalization of regulatory documents (e.g., briefing documents, protocols, submission materials, and agency responses).

Oversee internal and external (vendor) medical writing resources.

Ensure consistency, accuracy, and compliance with global regulatory requirements and ICH guidelines.

Manage document timelines, reviews, version control, and submission readiness.

Collaborate with subject matter experts across R&D to capture key information and messaging.

Translate complex scientific data into clear, structured content.

Design and maintain templated documents on digital platforms for efficient updates and integration.

Facilitate structured document reviews and resolve issues to meet deadlines.

Qualifications :

Bachelor’s or advanced degree in a life sciences discipline.

10+ years of medical or technical writing experience in the pharmaceutical or biotech industry.

Proven experience with NDA, BLA, or MAA submissions.

Strong understanding of regulatory and clinical development processes.

Skilled in using digital collaboration tools (e.g., SharePoint).

Excellent writing, editing, and communication skills.

Ability to manage multiple projects and collaborate effectively across functions.

Please apply directly if your experience aligns!

Seniorities Executive

Employment type Full-time

Job function Writing / Editing

Industries

Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Meet Life Sciences by 2x

Inferred from the description for this job Medical insurance

Vision insurance

Paid maternity leave

401(k)

Paid paternity leave

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