Associate Director - Medical Operations Excellence & External Engagement Manager

Medical Operations Excellence & External Engagement Manager

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 standard operating procedures (SOPs) as well as to the relevant local laws, regulations and local Industry Association Code of Practices. Can serve as a deputy of the Medical Operations Director.

Responsibilities include but will not be limited to the following key activities:

• Drive the implementation of our Research & Development Division -V&I GMSA policies, SOPs and guidelines at local level. Monitor and randomly 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 Resource, work instructions, references and other governing documents and resources when needed.
• Support Medical Operations Director to define the local Research & Development Division -V&I GMSA execution and priority in alignment with Medical Affairs Country Medical Director, local Legal & Compliance Dept. and HH Business Practices Manager. Performs periodic update to the Medical Operations team and the whole Medical Affairs.
• Serve as Single Point of Contact for excellence 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 of Medical Affairs for regional and global initiatives.
• Act as Medical Operations Country point of contact of Medical Affairs for Human Health interactions.
• Act as a point of contact between external stakeholder and internal stakeholder ensuring proper HCP Engagement activities.
• Advise Medical Affairs Operations Director and Country Medical Affairs Director on local processes issues or area of process improvement. Promptly suggest remediation plan.
• Coordinate local Medical Affairs communications on our Research and Development Division -GMSA quality system, policies and SOPs. 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.
• Know the basics of finance and give support in physician engagement and payment processes as well as bdg overall monitoring adapt the global procedures (Independent Medical Education, HCP engagement, Sunshine Act, Aggregate Spend, FMV, ..) to the local environment in order to define an effective operational local flow aiming to optimize resources, effort and improving operational accuracy and aligning with the local need and requirements.
• Data collection and data Analysis accountabilities including (KPI, aggregate spending, sunshine act, ..) to ensure quality but also medical excellence.
• Handle innovative projects and ideas in terms of execution in partnership with Med Modernization Ass Director.
• Improve the knowledge of our Research & Development division -GMA policies and local regulations, developing a solid understanding of compliance practices in the pharmaceutical industry including the Due Diligence check and Fair Market Value data review.
• Tackle complex challenges proposing innovative solutions and developing a proactive and creative approach to problem-solving in the execution of compassionate use program, LDG, IIS and events.
• Manage the Patient Engagement process with the aim to fulfill all global and local standards and requirements.
• Manage the C2C and GEMS activities with the aim to improve the standard process.
• Overview the LDG and IIS execution with the aim to improve the standard process.
• Develop and drive culture of ethic, compliance and integrity, innovation, digital and data driven process.

Your Profile

Qualification & Experience: A university degree in scientific fields, law, economics, or related areas is required, and IT and digital competencies are recommended. A minimum of 10 years of experience in the pharmaceutical industry is necessary, including at least 7 years in Medical Affairs. Experience in clinical research as well as in Field Medical and healthcare professional (HCP) engagement is highly desirable.

Skills:

• Strong analytical, organizational, and strategic thinking skills.
• Ability to work both independently and as part of multidisciplinary and cross-functional team to resolve complex matters.
• Communication skills (written/spoken).
• Ability to work in a global environment.
• Ability to author and review SOPs.
• Ability to drive and support local team in managing audits and inspections.
• Understand and apply data to make decisions that drive value for Medical Affairs and our customers.
• Think and act beyond one's silos– bridges boundaries across teams, functions, divisions, geographies, internal/external stakeholders and customers.
• High level English language knowledge is requested.
• IT and digital skills are strongly required.
• Understanding of the local regulatory environment, relevant international and local Codes of Practices, guidelines and regulations.
• Understanding of US FCPA is preferred.
• Comprehensive understanding of policies, SOPs, processes and systems is requested.
• Comprehensive understanding of Ex-US Standards is preferred.