**Hybrid, Local to Alameda, CA**
Job opportunity with a top biopharmaceutical company that is looking for a CMC Technical Writer to join their team on an 12-month contract with a possibility for conversion or extension!
Pay Rate: $55-$70/hr
- BA/BS and five years of experience in medical/technical writing; or,
- MA/MS and three years of experience in medical/ technical writing.
- Possess substantial Chemistry, Manufacturing, and Controls (CMC) knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation.
- Independently write and format CMC documents for US and global regulatory submission including:
- Module 2 and Module 3 CMC sections for development and post-approval dossiers in eCTD format
- CMC technical reports, including process and analytical validation summaries.
- Standard operating procedures for PSC department processes
- Interpret technical and scientific data as needed to prepare documents.
- Ensure that documentation conforms to International Conference on Harmonization (ICH) and other relevant regulatory guidelines; ensure that appropriate documented quality control (QC) checks are performed and recommend quality process improvements.
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?