Remote Technical Writer wanted (biologics) | $145 to $170 per hour
Added 2024-04-24 22:38:40 +0000 UTCCOMPANY/PUBLICATION: MEET
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
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.
THE QUALIFICATIONS
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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CONTACT INFORMATION:
Original job posting: Click here
Website: https://www.peoplewithchemistry.com/
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