The project analyst is the single point of contact regarding overarching as well as in-depth analytical assessments. As such you interact with a variety of internal and external customers and ensures the timely delivery of high quality analytical summaries in the form of key documents for development and submission.
- Be the single point of contact in analytics for internal and external
- Lead and plan analytical activities
- Ensure timely delivery of analytical project tasks in high quality
- Represent the analytical team in technical team meetings
- Closely interact with project management, regulatory CMC, and analytical experts
- Compile and review overarching documents with focus on analytics (e.g. analytical development masterplan, similarity assessment, DS/DP comparability)
- Participate in meetings with regulatory agencies (EMA, FDA)
- Participate in the compilation of briefing books, INDs, IMPDs and BLAs
- Together with experts on individual topics answer requests from authorities with a focus on analytics
- Present analytical project updates in internal and external meetings
- Contribute to budget planning activities
Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.
Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.