Regulatory Medical Writing Leader – Remote

Jobrapido; Sioux Falls (SD); Remote; USD 150,000 - 210,000; Full time

Job summary

Jobrapido seeks an Associate Director of Medical Writing (Regulatory) to lead the creation of clinical and regulatory documents for global filings. The role combines strategic leadership with hands-on writing, ensuring accuracy, consistency, and submission readiness across CTD components.

Remote work is possible for candidates in the United States, with a preference for someone near San Diego. The ideal hire will mentor junior writers, stay current on FDA/EMA/ICH guidance, and work closely with

Qualifications

• Bachelor’s degree required; advanced scientific degree preferred (PhD/PharmD/MD).
• 10+ years in medical writing within pharma/biotech with regulatory submissions.
• Proven track record leading global filing components (CTD summaries, CSRs, INDs, NDA/BLA).
• Strong skills in data interpretation, regulatory standards (FDA/EMA/ICH) and AMA style.

Responsibilities

• Lead authoring and end-to-end development of regulatory documents (CSRs, protocols, IBs, summaries).
• Represent medical writing on cross-functional teams with strategic input.
• Drive document strategy and key scientific messaging for regulatory submissions.
• Oversee timelines and deliverables to align with submission milestones.
• Ensure clarity, accuracy, and submission-readiness of documents.
• Mentor junior writers and maintain up-to-date regulatory knowledge.

Skills

Leadership

Strategic thinking

Regulatory writing

Cross-functional collaboration

Mentoring

Project management

Education

Bachelor's degree

Advanced scientific degree (PhD/MD/PharmD) preferred

Job description

Jobrapido seeks an Associate Director of Medical Writing (Regulatory) to lead the creation of clinical and regulatory documents for global filings. The role combines strategic leadership with hands-on writing, ensuring accuracy, consistency, and submission readiness across CTD components.

Remote work is possible for candidates in the United States, with a preference for someone near San Diego. The ideal hire will mentor junior writers, stay current on FDA/EMA/ICH guidance, and work closely with