Offer summary
Qualifications:
B.S., R.Ph., M.S., Ph.D. in scientific area with ≥ 10 years drug development experience, Scientific and regulatory knowledge of drug, biologic, or device development.
Key responsabilities:
- Assist clients in CMC and pharmaceutical development activities
- Lead HA communications and reviews/authors CMC-related regulatory content
- Contribute to strategic/CMC discussions, write regulatory/scientific documents
- Prepare product development plans/strategies, provide mentorship and guidance
- Manage projects, participate in meetings with clients, support staff development