Specialist Medical Affairs Operations (m/f/g)

Our client is a leading operating biopharmaceutical enterprise with a presence in more than 70 countries.

We are searching as soon as possible for a dedicated and experienced

Specialist Medical Affairs Operations (m/f/g)

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Your tasks

Operational IIT Management

  • Operational IIT management according to internal and external (legal) requirements
  • Tracking of IIT progress and filing of all relevant IIT documents (databases, document repositories)
  • Liaise closely with the respective local Medical Affairs Teams, Regulatory Affairs, Compliance and Drug Safety
  • Liaise with Global Medical Affairs Operations group and IMSC (Investigational Material Supply Chain) team
  • Establish local SOPs and Working Procedures where needed o Liaison with sponsor study managers and personnel ▪ IB, submission documents, status updates etc.
  • IIT-Budget Management (Controlling of invoices and local IIT budget) o IIT publication Tracking 

IIT Drug Supply Management

  • Primary interface to external IIT study managers/pharmacists  
  • Work closely with the IMSC team to plan and to manage all study supply activities
  • Operationally responsible person for CSPRs, shipment requests, forecasts 

Non-clinical Research Grant Management

  • Operational management of research grants according to Celgene and external (legal) requirements 
  • Tracking of research grant progress and filing of all relevant documents (databases, document repositories)

Your qualifications

  • Strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required.
  • Effective communicator: interpersonal and writing skills, motivation, flexibility and diplomacy.
  • Ability to handle multiple tasks and to prioritize. Strong organizational skills.
  • Extensive Word, PowerPoint and Excel skills, knowledge of database maintenance. 
  • Ability to manage complex communication and to establish lasting working relationships with internal and external partners. 
  • Excellent interpersonal skills
  • Can work within a team and independently
  • Flexibility, “Can Do attitude”. 
  • Fluent German/ English language skills, and able to work in an international environment. 

Your contact person

Natascha Lau
Personalberaterin Research


Optares ICM GmbH & Co. KG
Natascha Lau
Heiligengeist Höfe 8
26121 Oldenburg