Technical Writer Job

Technical Writer/RA Consultant Role - DACH - Remote

I am working with one of my key clients who are looking for a highly skilled technical writer/RA Consultant with a CMC focus to support a high-impact regulatory submissions project.

This role is focused on authoring and integrating technical documentation into global regulatory dossiers, with a strong emphasis on Drug Substance modules (particularly Module 3 – S section).

Requirements: - Proven experience as a Technical Writer in a CMC context, in the pharmaceutical or biotech industry. - Lead the preparation and integration of Module 3 – S section content for INDs, IMPDs, NDAs, and BLAs - Author and compile technical documentation for regulatory submissions, including: Risk assessments, Control strategies, Process descriptions - Strong understanding of drug substance development, including upstream/downstream processes and analytical characterization. - Familiarity with global regulatory frameworks (EMA, FDA, ICH). - Experience with Module 3 of the CTD, particularly the S section.

Contract: - Start Date: January 2026 - Length: 6/12 months - Hours: up to 40 hours per week - Location: Remote

If this is somethings that interests you, please send your CV to kyle.hansen@epmscientific.com

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