Project Manager (Pharmaceutical)

For one of our German clients in the region of München we are looking for a Project Manager with pharmaceutical experience. 

Activities

Support the following operational activities within the MOR208 BLA/MAA submission in close collaboration with Senior Program Manager and Regulatory Affairs (RA) representative:

• Closely work with and support Senior Program Manager and Regulatory Affairs in the process of MOR208 BLA/MAA submission

• Establish clear ownership for project tasks, ensure that team members have the tools needed, and provide timely feedback

• Track progress and review project tasks to make certain deadlines are met appropriately

• Identify and communicate critical processes or issues in projects and develop solution strategies together with Business Team Head, Senior Program Manager and/or functional representatives

Requirements

• Good understanding of drug development requirements and activities involving Nonclinical, Clinical, CMC, Regulatory Affairs, and Commercial aspects

• Degree in life science (e.g. Dipl. Biol., MSc., PhD) or equivalent relevant international work experience

• Experience in BLA and MAA submissions

• Experience in Program and/or Project Management in biological and/or drug development

• Know how to keep assigned projects on track, in scope and in budget

• Manage the assigned projects and cross-functional project teams

• Act as deputy for Senior Program Manager at MOR Excellent command of English and German B1

Start: ASAP
Inzet: 40 hours a week
Duur: 12 months with possible extension