Senior Medical Writing Director - Remote (US West)

Jobrapido; Dayton (OH); Remote; USD 180,000 - 240,000; Full time

Job summary

Jobrapido seeks an Associate Director, Medical Writing (Regulatory) to lead the development of complex regulatory documents for multiple programs. This senior role combines scientific leadership with strategic guidance, reporting to the Head of Regulatory & Medical Writing.

Remote work is possible for candidates located in the United States, with preference near San Diego for collaboration. The role emphasizes leadership in CTD submissions, cross-functional teamwork, and mentorship of junior

Qualifications

• Bachelor’s degree required; advanced scientific or clinical degree strongly preferred.
• 10+ years of medical writing experience in pharma/biotech with regulatory submissions.
• Experience leading global filings and CTD components (Clinical Overview, Clinical Summaries).
• Experience with CSRs, protocols, investigator brochures, INDs, NDA/BLA components.
• Strong data interpretation and presentation within regulatory documents.
• Familiarity with FDA, EMA, ICH guidelines (E3, E6).
• Ability to lead complex writing projects and manage competing priorities.

Responsibilities

• Lead authoring and development of regulatory documents (CSRs, protocols, I/Bs, NDA/BLA components).
• Represent medical writing on cross-functional teams and provide strategic input.
• Drive document strategy and ensure global regulatory alignment.
• Oversee timelines and submission readiness with program management.
• Translate clinical data into submission-ready docs with regulatory alignment.
• Manage document reviews and address comments for timely finalization.
• Coordinate with QA for audit readiness and with Regulatory Ops for formatting/publishing.
• Contribute to health authority responses and regulatory interactions.
• Mentor junior writers and promote team capability growth.

Skills

Leadership

Medical writing

Regulatory submissions

Strategic thinking

Scientific writing

Cross-functional collaboration

Mentoring

Project management

Education

Bachelor’s degree

Advanced degree (PhD/MD/PharmD)

Job description

Jobrapido seeks an Associate Director, Medical Writing (Regulatory) to lead the development of complex regulatory documents for multiple programs. This senior role combines scientific leadership with strategic guidance, reporting to the Head of Regulatory & Medical Writing.

Remote work is possible for candidates located in the United States, with preference near San Diego for collaboration. The role emphasizes leadership in CTD submissions, cross-functional teamwork, and mentorship of junior