Program / Project Manager Biotech (PR-33245706) München, Deutschland

Aplitrak - München - 23-08-2019 zur Vakanz  

For my client – a biotechnological company in the area of Munich – I am searching a Program and/or Project Manager in in the area of biological and/or drug development.

 

Program / Project Manager Biotech (m/w/n)

 

Your Responsibilities:

 
  • Closely work with and support Senior Program Manager and Regulatory Affairs in the process BLA/MAA submission
  • Establish clear ownership for project tasks, ensure that team members have the tools needed
  • Track progress and review project(s) tasks to make certain deadlines are met appropriately
  • Identify and communicate critical processes or issues in project(s) and develop solution strategies together with Business Team Head, Senior Program Manager and/or functional representative(s)
  • Support the following operational activities within the BLA/MAA submission in close collaboration with Senior Program Manager and Regulatory Affairs (RA) representative:
  • track internal filing plan for planned milestones and deliverables to ensure timely completion of the BLA dossier packages
  • internal and external (vendor) meeting organization with process tracking (generate agenda and minutes, agree on deliverables), monitor timelines & milestones and at vendor
  • monitor timelines and progress of deliverables & tasks according to internal plan and vendor BLA Project Plan to ensure alignment
  • initiate review/adjudication and approval cycles for the BLA relevant documents within the Regulatory Management system (RegDMS)
  • act as deputy for Senior Program Manager
 

Your Skills set:

 
  • Good understanding of drug development requirements and activities involving Nonclinical, Clinical, CMC, Regulatory Affairs, and Commercial aspects
  • Experience in Program and/or Project Management in biological and/or drug development and in the management of cross functional (development) teams
  • Excellent communication and presentation skills
  • Ability to lead, to give guidance and to motivate and develop project team members
  • Ability to integrate people and opinions, to derive consolidated plans and to resolve conflicts
  • Ability to translate a strategic vision into a project plan with associated activities and timelines
  • Strong team player attitude
  • Work with a high level of motivation and own initiative, show a pronounced organizing ability
  • Excellent command of English
 
 
 
 
Volume: full time
Start: to earliest possible date
 
Location: Munich
Limited to 12 month (Permanent or freelance) with a realistic option for a permanent position afterwards
mehr...

zur Vakanz

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