Medical Compliance Manager

Medical Compliance Manager

Takeda AS

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

Join us as a Medical Compliance Manager in Asker, Norway.

ROLE OBJECTIVE
Medical Compliance Manager /Nominated signatoryfor all promotional and non-promotional materials. The Medical Compliance Manager is responsible for ensuring that the company is following all local laws and regulations and all Takeda regulations regarding the development, review, approval and dissemination of promotional and non-promotional materials linked to Takeda products or disease areas. This includes training and guidance of Takeda personnel, oversight of systems and processes and drafting and developing SOPs and work instructions.

ACCOUNTABILITIES

  • Approval of activities
  • Support Medical director and medical team in execution of activities linked to hcp, including follow up of training, screens activities related to hcp before approval by Medical Director to ensure compliance with local and global rules and regulations
  • Certifier in Promo mats according to local Work aid.

Medical Compliance Manager supports the medical team in project execution, including:

  • SOP gap assessment (relevant SOPs)
  • Writing and reviewing SOPs related to medical activities
  • Ad hoc support for Medical department projects

SKILLS and COMPETENCIES

  • PharmD or relevant master’s degree in life science
  • LMI training
  • Experience working as Medical compliance manager/ nominated signatory, or other relevant experience from Pharma industry