To strengthen HELM´s Interdisciplinary Program team of Onconcept & Specialty Generics in the field of generic pharmaceutical development we are looking for a
(Senior) Manager Pharmaceutical Development (m/f/d)
Your tasks:
1. Your role will include the coordination of all technical as well as scientific project activities and tasks within pharmaceutical development - from project start to product launch.
2. You will be responsible for defining a pharmaceutical development strategy. As an interface to external partners, you will be responsible for the implementation, management and control of the development strategy.
3. In addition, you will identify possible partners (API - and FDF) for the business unit in cooperation with our colleagues from Strategic Procurement. This implies the evaluation of the corresponding ASMF and CMC documentation.
4. You will support the dossier creation in the international environment as well as the response to deficiency letters.
5. Moreover, you love to share your knowledge and offer support to all colleagues in the Business Unit Pharma regarding scientific issues.
6. The answering of customer queries within the scope of due diligence completes your area of responsibilities.
Your profile:
7. You have a degree in natural sciences as well as initial work experience within a scientific field (pharmaceuticals, chemistry).
8. Moreover, you have experience in the international pharmaceutical environment - ideally in pharmaceutical development. In addition, you can demonstrate experience with US and EU regulations in this context.
9. You are familiar with common IT applications within the framework of project management (MS Office). In top of that, you already gained experience in working with SAP or another ERP system.
10. In a team you will act as an open and communicative contact person. You enjoy accompanying projects within pharmaceutical development. Motivated, you will also accept new challenges.
11. Fluent spoken and written English skills complete your profile.