Junior Regulatory - CMC technical writer
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
As a Junior Regulatory-CMC Technical Writer you will be responsible for (co)-authoring documents such as IMPDs, CMC sections of INDs and Module 3 sections for BLA/MAA submissions and authority scientific advice meeting packages, as well as environmental risk assessment documentation and summary documents.
- Authoring, coordinating and reviewing of CMC documents for CTAs/INDs; briefing books; health authority response documents
- Lead review cycles in close collaboration with RA, CMC and GMP functions (process and product development, analytical development, manufacturing, quality control and GMP quality assurance)
- Develop documentation frameworks and define which source documents are needed to support submissions
- Project management/coordination of technical writing and reviewing activities between the internal team and external subject matter experts
- Ensure that the documentation is of high quality
- Ensure that all documents meet relevant national, regional and global regulatory requirements
- Maintain IND/IMPD templates, dossier tracking sheets and health authority question & answer tracking sheets
- PhD or MSc (Bio-sciences e.g. biotechnology, virology, biochemistry, molecular biology, pharmaceutical sciences).
- Experience from biotech/pharmaceutical industry advanced therapy medicinal products (ATMPs), biologicals or vaccines
- Hands-on technical writing experience in IMPD/IND filings, substantial amendments, scientific advices, and other regulatory documents; having experience with GMO/ERA submissions, and BLA/MAA filings is preferred
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.