Remote Associate Director, Medical Writing (Regulatory)

Jobrapido; Omaha (NE); Remote; USD 120,000 - 160,000; Full time

Job summary

Jobrapido is seeking an Associate Director of Medical Writing (Regulatory) to lead the development of regulatory documents across programs. Remote role with preference for candidates near San Diego.

You will author CSRs, protocols, IBs, and CTD components, guide scientific messaging, manage timelines, and ensure submission readiness while mentoring junior writers and collaborating with QA and Regulatory Operations.

Qualifications

• Bachelor’s degree required; advanced scientific or clinical degree strongly preferred.
• Approximately 10+ years of medical writing experience in pharma/biotech with regulatory submissions.
• Demonstrated leadership in authoring CTD components and global filings.
• Experience mentoring junior writers is valued.
• Familiarity with FDA/EMA/ICH guidelines and AMA style.

Responsibilities

• Lead authoring of CSRs, protocols, investigator brochures, NDA/BLA components and CTD summaries.
• Serve as medical writing lead on cross-functional teams and guide scientific messaging.
• Drive document strategy and ensure consistency across deliverables.
• Oversee timelines and submissions aligned with regulatory milestones.
• Translate complex data into submission-ready docs and ensure regulatory compliance.
• Manage document reviews, resolve comments, and ensure finalization.
• Collaborate with QA to address findings and ensure inspection readiness.
• Support Regulatory Operations in formatting and publishing for submissions.
• Contribute to responses to health authority inquiries as needed.
• Provide mentorship and leadership to junior writers.
• Keep up-to-date with global regulatory guidance and best practices.

Skills

Leadership

Strategic writing

Regulatory writing

Cross-functional collaboration

Mentoring

Regulatory knowledge

Education

Bachelor's degree

Advanced degree (PhD/MD/PharmD) preferred

Job description

Jobrapido is seeking an Associate Director of Medical Writing (Regulatory) to lead the development of regulatory documents across programs. Remote role with preference for candidates near San Diego.

You will author CSRs, protocols, IBs, and CTD components, guide scientific messaging, manage timelines, and ensure submission readiness while mentoring junior writers and collaborating with QA and Regulatory Operations.