Vacancy expired!
CMC SUBMISSIONS WRITER DURHAM, NC Required Skills:
- Scientific and educational background (B.Sc. or MSc) to understand pharmaceutical drug development concepts, regulatory concepts and create documentation based on these concepts .
- Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance .
- Excellent project management skills .
- Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents .
- Good writing skills for technical writing .
- Detail oriented and highly organized .
- Good verbal communication skills for leading meetings and remote interactions .
- Work well in team setting on a fast-paced business critical project .
- Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company .
- Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation .
- Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders .
- Assist with ongoing GXP systems transition, related to change control and regulatory dossiers .
- Ad hoc RACMC support to line manager .
- Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
- The outlined tasks may be subject to change as the workload of the business requires .
Vacancy expired!