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Medical Affairs Excellence Manager
Provides operational support to the Medical Organization on the execution of local medical trials/projects within Medical Affairs and contributes to identifying and maintaining all the actions needed to ensure training & compliance of the medical processes and the Medical Affairs team.
De functie / The role
Establish and implement functional excellence across the Medical Affairs team by coordinating medical processes within the team, and business processes impacting the team.
- Ensures audit and inspection readiness of the Country Medical Affairs Teams, in collaboration with the Country Medical Affairs Heads and CPO Quality Department.
- Establish processes and oversee all local clinical projects such as IITs, NIS (non-interventional studies), LIS (local interventional studies) MAPs (CUPs /MNPs/ IPPs/ ETA (early temporary access)/ ETR (early temporary reimbursement)) to ensure, together with the Country Medical Heads, the execution in a timely and quality manner, according to local law and regulations, SOPs, WPs and NP4.
- Ensure clinical operational support and expertise in collaboration with the Country Medical Heads/Medical advisors/MSLs to ensure local IITs are implemented in a timely manner according to the current guidance.
- Implement and secure operational support to local NVS NIS and registries in collaboration with study leads (MA/MSL) such as: MRC and PRC approval via GMA Vision, contract negotiation and execution, selection of vendor and CRO process and ensure the CSRs (Clinical Study Reports) are compiled in accordance to Novartis SOPs and financial management including phasing.
- Perform accurate tracking of Novartis sponsored local studies (IS/NIS), IITs and CUPs /MNPs/ IPPs/ ETA/ETR in required databases and registries in collaboration with the MICOS/Medical Affairs Operational Specialist.
- Point of contact in local and region (WEC/RE) meetings/task forces to support continuous improvement in harmonization of processes across the Medical Organization, maintaining peculiarities and specific needs for the different medical line units, when needed, always with respect of compliance of medical processes.
- Provides guidance on training requirements in relation to medical processes including SOPs and written guidance documentation for Medical Affairs associates and track that trainings are performed. Act as the go to person for all Medical Affairs members.
- Establish and implement functional excellence across the Medical Affairs team by coordinating medical processes within the team and business processes impacting the team, such as strategic and operational planning processes, cross functional working processes and ensure consolidated response from the Medical Organization Cluster to WEC/RE and Global requests.
- Support the Country Medical Heads and Medical Director to assure delivery of strict financial targets & cost control metrics against targets for all in-scope medical activities.
- Responsible for audit and inspection preparation related to the Country Medical Affairs Teams, by creating and setting up plans as needed, in close collaboration with members of the Medical Leadership Team/Country Head Medical Affairs and CPO Quality Assurance. Build a close collaboration with QA and drive the compliance agenda on the Medical leadership team meetings.
- Accountable together with Country Medical Heads for training assignment for each function, and development of clear training plans ongoing for each function.
- Develop and maintain clear medical on-boarding plans for all medical associates roles
Het profiel / Your profile
Education (minimum/desirable): Scientific degree,
Languages: Dutch, English fluent
o Strong communication and trainings skill.
o Knowledge of both scientific and operational aspects of clinical drug development.
o Familiar with respective health authority, GCP and ICH requirement.
o Strong process excellence skills
o Successful development and implementation of innovative programs and processes.