Description
We are looking for a
Medical Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 3 MM+
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Provide strategic consultancy to GMA/RMA/LMA in terms of study proposals and the overall management of clinical studies
- Manage and set up of Decision boards for data sharing and patient support programs
- Support CMO office in daily business in terms of governance and compliance
- Develop and maintain strong, mutually supportive working relationships and collaboration with each of the departments within GMA/GDS as well as key stakeholders within Global R&D
- Conceptual design support of study proposals, provide expert input to GCP, insurance, compliance, regulatory and legal related aspects of medical affairs studies (local studies, Investigator sponsored studies)
- Support the secretary of the decision board of assigned therapeutic areas, ensure cleaning and review process in regards to scientific, conceptual and design maturity of Medical Affairs study proposals
- Track and traceability of the status of all Medical Affairs Trials and act pro-actively on any identified issue to support resolution of them
- Management, maintenance and administration of Medical Affairs owned data systems – automated tracking tool and proposal/trial review and tracking management system
- Ensure compliance with GCP and all valid guidance’s and regulations in regards to Medical Affairs Trials
- Implementation and continuous improvement of quality- and compliance-oriented quality documents and processes
Your qualifications
- University degree (life science, medicine, chemistry)
- Basic understanding of clinical research and of development process
- Governance and compliance themes
- Application of different communication tools and channels
- Managing international and interdisciplinary project teams
- English business fluently
- Change management experience
Skills:
- Medical affairs manager
Keywords: Medical affairs Manager