Medical Affairs Manager (m/f)

REFERENZNUMMER:

318366/1

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Medical affairs manager