CMC Technical Writer, Director
Company Summary:
My client, a clinical stage biopharmaceutical company, is focused on delivering treatments to help patients who currently have no other treatment options suffering from liver and cardiometabolic diseases. They are looking to add a CMC Technical Writer Director to their team on a hybrid basis to their site in San Francisco!
The CMC Technical Writer Director will be responsible for:
- Authoring and reviewing technical reports required by CMC function leaders.
- Authoring and compiling CMC sections of regulatory submissions including INDa, IMPD, QOS, briefing book, BLA, etc.
- Collaboration with CMC SMEs for preparation of CMC sections of the regulatory dossiers including IND, INDa, briefing documents , regulatory responses and BLA.
- Managing integrated drafting and review process following aggressive filing timelines.
The CMC Technical Writer Director should have the following qualifications:
- Bachelor's degree and 5+ years of experience in CMC regulatory filing.
- Strong working knowledge of full spectrum of CMC and strong technical writing skills.
- Experience with preparation of CMC sections of regulatory dossiers in eCTD format.
