Remote Regulatory Medical Writing Leader

Jobrapido; Columbus (OH); Remote; USD 140,000 - 190,000; Full time

Job summary

DaMar Staffing seeks an Associate Director of Medical Writing (Regulatory) to lead the creation of high‑quality regulatory documents across programs. This senior role guides CTD summaries, CSRs, protocols, and briefing packages, partnering with cross‑functional teams and ensuring submission readiness.

The ideal candidate has 10+ years in medical writing within pharma/biotech, strong leadership, and a solid grasp of FDA/ICH guidelines.

Qualifications

• Bachelor’s degree required; advanced scientific or clinical degree strongly preferred.
• 10+ years of medical writing experience within pharma/biotech with regulatory submissions exposure.
• Extensive experience authoring global filings including CTD summaries (Clinical Overview, Clinical Summaries).

Responsibilities

• Lead authoring and development of CSR, protocols, investigator brochures, and NDA/BLA components.
• Serve as medical writing representative on cross-functional teams and provide strategic input.
• Drive document strategy and scientific messaging for regulatory submissions.
• Oversee timelines and deliverables with program management to meet submission milestones.
• Translate data into submission-ready documents aligned with global standards.
• Manage review cycles, resolve comments, and ensure timely finalization.
• Collaborate with QA to address audit findings and inspection readiness.
• Support Regulatory Operations with formatting, publishing, and submissions.

Skills

Medical writing leadership

Regulatory submissions

CTD/Regulatory documents

Cross-functional collaboration

Mentoring

AMA style

Education

Bachelor’s degree

Advanced degree (PhD/MD/PharmD) preferred

Job description

DaMar Staffing seeks an Associate Director of Medical Writing (Regulatory) to lead the creation of high‑quality regulatory documents across programs. This senior role guides CTD summaries, CSRs, protocols, and briefing packages, partnering with cross‑functional teams and ensuring submission readiness.

The ideal candidate has 10+ years in medical writing within pharma/biotech, strong leadership, and a solid grasp of FDA/ICH guidelines.