Have you worked with Module 3 Dossiers within a CMC environment and are looking for your first opportunity working outside the lab in an exciting and rapidly growing company?
Job Title: Dossier Development Scientific Writer
Type: 6 Month temp - Potential to extend
Salary: DOE and Negotiable
Location: Hull, England, Hybrid - Remote working is possible for the right candidate.
SRG is currently working exclusively with a global specialty pharmaceutical company that is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease.
As a result of expansion, we are looking for an analytical chemist who has experience working with Module 3 CMC Dossiers to join the dossier team on a 6 month initial contract to support with a range of critical projects. This is a GREAT opportunity to gain experience within CMC regulatory writing, and could open the door to Regulatory Affairs positions.
If you have worked on any of the following sections, please get in touch! Please outline in your CV how you fit the below requirements.
Module 3
32S Drug Substance
32S1 General Information
32S2 Manufacture
32S3 Characterization
32S41 Control of Drug Substance
32S5 Reference Standards or Materials
32S6 Container Closure System
32S7 Stability
32P Drug Product
32P1 Description and Composition of the Drug Product
32P2 Pharmaceutical Development
32P3 Manufacture
32P4 Control of Excipients
32P5 Contr...