CMC Writer’s primary responsibility is to ensures smooth progress of regulatory CMC submissions to health authorities. They involves in regulatory CMC submissions – applying intelligence and developing regulatory strategy. Here are the sample job description of the CMC Writer.
Key Responsibilities of CMC Writer
- Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
- Support the coordination and preparation of timely CTD file for submissions.
- Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
- Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
- Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Understands, interprets and advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of applications.
- Identify, communicate and escalate potential CMC regulatory issues, as needed
- Help establish regulatory CMC submission processes and procedures.