Associate Director, Regulatory Medical Writing

Jobrapido; Richmond (VA); Remote; USD 150,000 - 190,000; Full time

Job summary

DaMar Staffing seeks an Associate Director, Medical Writing (Regulatory) to lead the development of regulatory documents across programs. This senior role, reporting to Head of Regulatory & Medical Writing, can be remote but prefers candidates in the United States with West Coast hours.

You will author CSRs, protocols, IBs, and CTD modules, collaborate with cross-functional teams, manage timelines, ensure QA readiness, and mentor junior writers while staying current with FDA, EMA, ICH guidelines

Qualifications

• Bachelor’s degree required; advanced scientific or clinical degree strongly preferred.
• Approximately 10+ years of medical writing experience within pharma/biotech with regulatory submissions.
• Leadership in authoring CTD summaries and global filings (e.g., Clinical Overview, Clinical Summaries).
• Experience developing core documents such as CSRs, protocols, investigator brochures, INDs, NDA/BLA components.
• Strong expertise in safety/efficacy data interpretation within regulatory documents.
• Familiarity with FDA/EMA/ICH guidelines (E3, E6) and regulatory standards.
• Ability to lead complex projects and mentor junior writers.

Responsibilities

• Lead authoring and end-to-end development of complex regulatory documents (CSRs, protocols, IBs, briefing packages, CTD summaries).
• Serve as medical writing representative on cross-functional teams.
• Drive document strategy and scientific messaging for regulatory submissions.
• Oversee timelines and ensure alignment with submission milestones.
• Translate complex data into submission-ready documents.
• Manage review cycles and cross-functional input.
• Collaborate with QA to address audit findings and inspections readiness.
• Support regulatory interactions and responses to authorities.

Skills

Regulatory medical writing

Leadership

Cross-functional collaboration

Regulatory submissions

FDA/EMA/ICH knowledge

Education

Bachelor’s degree

Advanced scientific degree (PhD/PharmD/MD)

Job description

DaMar Staffing seeks an Associate Director, Medical Writing (Regulatory) to lead the development of regulatory documents across programs. This senior role, reporting to Head of Regulatory & Medical Writing, can be remote but prefers candidates in the United States with West Coast hours.

You will author CSRs, protocols, IBs, and CTD modules, collaborate with cross-functional teams, manage timelines, ensure QA readiness, and mentor junior writers while staying current with FDA, EMA, ICH guidelines