Contact: Alexandra Spink - [email protected] No 3rd party candidates We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities. This role focuses on independently updating and finalizing regulatory documents to support ongoing agency interactions and submission deliverables, working alongside internal and contract writers. Scope of Work

• Independently update, revise, and finalize regulatory documents, including protocol and IB
• Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2–5) across the submission lifecycle (responses, amendments, briefing packages)
• Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents
• Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards
• Support intermittent workload demands (~10–15 hours/week during active project periods)

Qualifications

• Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions
• Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages)
• Ability to work independently with minimal oversight in a fast-paced, cross-functional environment
• Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards
• Proven collaboration experience with regulatory, clinical, and medical writing teams