CMC Writer

A company is looking for a CMC Writer to focus on regulatory affairs within the oncology and biotechnology sectors. Key Responsibilities Manage Module 3 deliverables for US and EU filings, including new sections and updates Lead the writing process for NDA and MAA submissions, along with follow-on variations and supplements Coordinate with global experts and contract manufacturing organizations to gather necessary data Required Qualifications Extensive experience in CMC medical writing for small or large molecules Proven leadership in NDA and MAA submissions Ability to work independently and manage multiple projects simultaneously

Jun 17, 2025 - 13:20

A company is looking for a CMC Writer to focus on regulatory affairs within the oncology and biotechnology sectors. Key Responsibilities Manage Module 3 deliverables for US and EU filings, including new sections and updates Lead the writing process for NDA and MAA submissions, along with follow-on variations and supplements Coordinate with global experts and contract manufacturing organizations to gather necessary data Required Qualifications Extensive experience in CMC medical writing for small or large molecules Proven leadership in NDA and MAA submissions Ability to work independently and manage multiple projects simultaneously