CMC Technical Writer
Location: London or Remote
Company is seeking an experienced CMC technical writer to prepare and draft CMC content for global regulatory filings such as Investigational New Drug (IND) Applications, Investigative Medicinal Product Dossiers (IMPD), Biologics License Applications (BLA), Marketing Authorization Applications (MAA) and CMC sections of Health Authority Meeting Briefing Books. The technical writer will work in close collaboration with the Regulatory CMC lead and will liaise with key CMC functions, draft needed regulatory content, and collaborate in cross-functional team reviews of the drafted documents.
You will have at least 3-5 years experience in this role. For more information please get in touch to discuss this role.