What are the responsibilities and job description for the CMC Writer position at Maxis Clinical Sciences?
- Bachelor's degree (or advanced degree) in chemistry, pharmaceutical sciences, or related field
- Prior experience authoring CMC sections for regulatory submissions (IND, NDA, BLA, or MAA)
- Experience with both US-FDA and EU (IMPD/MAA) regulatory submissions
- Strong knowledge of FDA, EMA, and ICH CMC regulatory requirements
- Ability to write and review documents in eCTD format
- Experience collaborating with cross-functional teams (e.g., regulatory affairs, manufacturing, scientists)
- Experience with Investigator Brochures, Briefing Documents, DSUR/AR/RTQ submissions, and responses to health authorities
- Strong technical writing and documentation skills for regulatory submissions
- Proven ability to follow regulatory templates and guidelines
- Ability to identify and escalate CMC regulatory risks
Nice to have:
- Project management