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Associate director

San Gregorio da Sassola
Contratto a tempo indeterminato
Msd Italia
Pubblicato il 13 ottobre
Descrizione

Overview The Medical Operations Excellence & External Engagement Manager is responsible for overseeing various activities of the local Medical Affairs team and ensuring adherence to applicable Research & Development Division - GMSA policies and SOPs, as well as to relevant local laws, regulations and local Industry Association Code of Practices. This role can serve as a deputy of the Medical Operations Director. Responsibilities Drive the implementation of Research & Development Division - V&I GMSA policies, SOPs and guidelines at local level. Monitor and perform quality control and compliance assessments after local SOPs and policies implementation. Ensure that local Research & Development Division - V&I GMSA policies and SOPs are compliant with local laws, regulations and local Industry Association Code of Practices. Author local SOPs, execution resources, work instructions, references and other governing documents and resources when needed. Support Medical Operations Director to define local Research & Development Division - V&I GMSA execution and priority in alignment with the Medical Affairs Country Medical Director, local Legal & Compliance Dept. and HH Business Practices Manager; perform periodic updates to the Medical Operations team and the entire Medical Affairs organization. Serve as Single Point of Contact for excellence in execution of Input Meetings, Independent Medical Education, Local In-Country Non-Promotional Medical Education Programs, Management of Medical Affairs Procedural Documentation, Global Field Medical, Medical Affairs initiated Local Sponsorships to Institutions / Medical Associations / Organizations, Local data Generation & Non-interventional Studies, Investigator Initiated Studies and Compassionate Use Programs, and External vendor qualification and Engagement. Act as Medical Operations Country point of contact for regional and global initiatives. Act as Medical Operations Country point of contact for Human Health interactions. Act as a point of contact between external stakeholders and internal stakeholders to ensure proper HCP Engagement activities. Advise Medical Affairs Operations Director and Country Medical Affairs Director on local processes issues or areas of process improvement; promptly suggest remediation plans. Coordinate local Medical Affairs communications on Research and Development Division - GMSA quality system, policies and SOPs; serve as Global Subject Matter Expert for policies and SOPs archive system. Collaborate across boundaries with functional teams, including HH, to ensure readiness for audits and inspections. Actively drive and participate in audits and inspections. Provide guidance to Medical Affairs on process updates while gaining cross-functional and cross-Country alignment. Organize work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery. Plan and deliver ideas and information to others in a clear and impactful manner. J-18808-Ljbffr

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