A new exciting opportunity has arisen for a Senior Manager, Global Medical Affairs to join us in Amsterdam. In this role you will be a global strategic partner across Tevas therapeutic areas supporting Global Launch Management, Medical Processes, GMA Operational Excellence. You will oversee the processes associated with and the governance of the management of GMA lead clinical studies, compassionate use programs and global ISS coordination and governance.
As a Senior Manager, Global Medical Affairs you will interact directly with internal and external stakeholders in order to ensure the timely execution of medical activities on time and on budget. You will be also responsible for maintaining policies and SOPs essential for compliance.
Global Medical Launch Management:
Supporting Global and Regional Medical Affairs teams with the execution of Medical launch plans including but not limited to Ajovy, Austedo and fasinumab.
Timely execution of launch plan by aligning monthly with medical functions to manage and update the medical launch plan.
Risk identification and mitigation planning; working with medical functions to identify risks, develop mitigation plans and maintain risk register.
Working closely with medical functions to update KPIs to measure teams success.
Medical Affairs Excellence:
Development of various SOPs and Work Instructions related to Excellence and Compliance in the execution of Global Medical Affairs led activities, in alignment with the Specialty R&D Systems and Standards team, Specialty Clinical Development and Global Medical Affairs.
Budget support for Therapeutic Areas:
Summarize monthly spend reports from Finance.
Schedule and facilitate monthly budget meetings with stakeholders from GMA and GCO.
Collate Global HQ AOP budgets and medical plan presentations for submission to Sr. Leadership.
Governance and global study oversight responsibility for CSS, ISS and compassionate use and expanded access programs (CUP/EAPs).
Governance, oversight and coordination of Medical Affairs sponsored studies, and support for MARC meetings as needed.
Governance, oversight and coordination of the Investigator Sponsored Studies, support for IRC meetings including partner with compliance and legal as needed regarding appropriate ISS program oversight.
Tracking of EAPs and CUPs across TAs.
Developing and aligning stakeholders regarding data generation planning for:
Inclusion in the Medical Plan (and Launch plan, where applicable).
Guidance for medical teams late phase study design and execution.
Dovetailing with clinical development plans for fully lifecycle evidence generation of assets.
Assisting with study start up activities in partnership with GCO and Procurement; e.g. SDC/protocol development, vendor selection, convene study team, MARC presentation.
Development and refinement of relevant policies, SOP and Work Instructions.
Working with internal stakeholders across regions, TAs and departments to facility successful processes for data generation including late phase study development and launch as well as Investigator Sponsored Studies programs.
Bachelor’s degree, ideally in a job-related field.
Significant Medical Affairs experience, ideally with an international/global exposure.