Senior Medical Writing Lead, Regulatory (Remote)

Jobrapido; Boise (ID); Remote; USD 140,000 - 190,000; Full time

Job summary

DaMar Staffing seeks an Associate Director of Medical Writing (Regulatory) to lead the development of regulatory documents across programs. Remote work is possible for candidates located in the United States, with West Coast hours required.

The role focuses on authoring CSRs, protocols, investigator brochures, and CTD summaries, while guiding cross-functional teams to ensure submission readiness. A strong background in FDA/EMA/ICH guidance and 10+ years of pharma/biotech writing is required.

Qualifications

• Bachelor’s degree required; advanced degree strongly preferred.
• 10+ years of medical writing experience in pharma/biotech with regulatory submissions.
• Experience leading CTD summaries and core regulatory documents (CSRs, INDs, NDA/BLA).
• Ability to manage complex projects, mentor junior writers, and ensure QA and submission readiness.

Responsibilities

• Lead authoring of CSRs, protocols, investigator brochures, and CTD Module 2 summaries.
• Serve as medical writing lead on cross-functional teams and provide strategic input.
• Set document strategy and ensure consistency across deliverables.
• Oversee timelines, quality control, and submission readiness with QA and Regulatory Ops.
• Mentor junior writers and stay updated on global regulatory guidance.

Skills

Regulatory writing

Leadership

Regulatory guidance knowledge (FDA/EMA

Education

Bachelor’s degree

Advanced scientific/clinical degree (PhD/PharmD/MD)

Job description

DaMar Staffing seeks an Associate Director of Medical Writing (Regulatory) to lead the development of regulatory documents across programs. Remote work is possible for candidates located in the United States, with West Coast hours required.

The role focuses on authoring CSRs, protocols, investigator brochures, and CTD summaries, while guiding cross-functional teams to ensure submission readiness. A strong background in FDA/EMA/ICH guidance and 10+ years of pharma/biotech writing is required.