Senior CMC Writer
624000 DKK - 936000 DKK om åretGenmab
Genmab seeks a Senior CMC Writer to author and coordinate regulatory submission documents for global biologics applications, including BLAs and MAAs. The role involves transforming complex manufacturing and control information into clear regulatory documents while mentoring colleagues and leveraging AI tools for documentation improvement.
Responsibilities
- Independently author and coordinate Module 3 CTD sections covering manufacturing, controls, analytical procedures, and stability
- Resolve health authority review comments and deliver approved documents within agreed timelines
- Serve as senior reviewer for scientific accuracy, regulatory alignment, and document quality consistency
- Author and coordinate responses to health authority questions across submissions and programs
- Support late-stage filings, global rollouts, lifecycle maintenance, and post-approval changes
Requirements
- Master's degree in science or related technical discipline
- Minimum six years CMC or related pharmaceutical/biotechnology industry experience
- Direct experience supporting IND, CTA, BLA, MAA, or NDA filings
- Expertise authoring and reviewing complex CMC regulatory sections independently
- Strong knowledge of CTD structure, GxP requirements, and regulatory expectations
- Practical experience using AI to improve scientific writing quality and efficiency
- Excellent written English and ability to communicate complex information clearly
Compensation: DKK 624,000–936,000 base annual
Ledig stilling opslået Indrykket for 2 dage siden
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