- Lead the comprehensive drafting and review process, ensuring adherence to tight filing deadlines.
- Collaborate closely with CMC SMEs to develop CMC sections for various regulatory dossiers, including INDs, IND amendments, briefing documents, regulatory responses, and BLAs.
- oversee a team of technical writers, offering mentorship and assistance to uphold the standard of documentation excellence.
- Efficiently manage feedback from regulatory agencies, ensuring prompt responses and implementation of necessary actions.
- Conduct thorough reviews of source documents to maintain consistency, completeness, and high quality.
- Bachelor's degree in a relevant scientific discipline; advanced degree (PhD or MS) preferred.
- Proven experience in CMC technical writing within the biologics sector, with a focus on late-phase programs.
- Proficient in all aspects of CMC, including cell bank, drug substance, drug product, analytical, formulation, and GMP manufacture.
- Experience with CMC sections of regulatory dossiers in eCTD format, BLA filing experience preferred.
- Strong technical writing skill is required.
- Excellent communication and collaboration skills to work effectively with cross-functional teams.
- Detail-oriented with a commitment to producing accurate and high-quality documentation.
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AD/ Director CMC Technical Writer - California, United States - Meet
Description
THE COMPANY
Our client is a biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases.
THE ROLE
We are looking for a dynamic and experienced AD/Director of CMC Technical Writing with expertise in biologics to join there team. The successful candidate will play a pivotal role in being responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings
THE RESPONSIBILITIES
THE QUALIFICATIONS
