Global Medical Affairs Manager

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Overview:

The Global Medical Affairs Manager is part of the Medical Affairs Team and represents the nexus of cutting-edge medical and scientific insights with internal and external stakeholders contributing to drive medical innovation in the therapeutic areas of competence and throughout the entire product life cycle.

Reporting to the Global Medical Affairs Lead, he/she is in charge for active and value-adding scientific contributions to cross-functional teams internally and engagement with key external stakeholders.

Reports to: Global Medical Affairs & Clinical Operations Director;

Contract: temporary (12 months).

Main Activities & Responsibilities:

Serve as the primary scientific and medical expert for the assigned therapeutic area/products with internal and external stakeholders. Participate as representative of Global Medical Affairs in Global Project Teams/Global Brand Team. Contribute to the development and execution of the Global Medical Affairs Plan/ Menarini Marketing Multichannel Model (M4) according to strategic company milestones and budget.
Work closely with internal stakeholders to ensure that all activities in the Medical Affairs Plan/Menarini Marketing Multichannel Model (M4) designed to meet shared objectives are implemented and performed in a timely manner. Contribute to marketing strategies with scientific input and collaborate on organizing medical events.
Provide impactful feedback/information to internal stakeholders on emerging clinical and scientific trends from external interactions to help shape company research and to ensure the safe and appropriate use of Menarini Group products. Build specific excellence and integrity within the healthcare community.
Develop contacts with key clinicians, patient’s association and other medical/scientific groups. Contribute to Mapping of Key Opinion Leaders (KOLs) on the disease and KOLs insights on the product. Analyze, synthesize, and present medical scientific information in a structured way.

Prepare and deliver training sessions on therapeutic areas and assigned products.

Assist in the development and execution of clinically relevant medical meetings (e.g., advisory boards, consultancy and investigator meetings), as requested.
Contribute to planning, coordination, and presentations at global and national advisory boards and other meetings.
Contribute to publication planning, delivery, and dissemination.
Contribute to the development and implementation of key international congresses
Develop, review and approve responses to unsolicited requests for medical information in line with
company’s SOPs and code of practice.
Develops, review and approve promotional and educational materials for the allocated therapeutic area.
Act as Study Medical Expert in the development of studies from initiation until publication and evaluate initiated investigator studies in the correspondent therapeutic area.
Interact with key medical societies.
Support and review of grants for scientific projects in collaboration with clinical operations.
Provides support and input into regulatory authority interactions, for example RMPs, PSURs, defending risk/benefit, Product Information.
Provides support and input into early phase or market access aspects of clinical development plans.
Contribute to developing SOPs and Working Instructions to improve efficiency, quality and compliance in processes.

Coordinate approval of contracts for external (consultancy/speaker) activities with HCPs or other third parties.

Collaborate with external providers in different activities according to the Menarini Group code of
practice and policies.
Ensure all medical projects, materials and presentations are compliant to pharmaceutical codes.

Act within compliance and legal requirements as well as within company guidelines.

Job Requirements:

  • Medical Doctor Degree;
  • Business fluency in English, both spoken and written;
  • Good verbal and written communication skills;
  • Strong organizational, and cross-functional collaboration skills;
  • Driven by Learning & Personal Development;
  • Ability to effectively collaborate in a dynamic and global environment;
  • Strong comprehension of disease states, knowledge of differential algorithms for treatment decisions, and experience in disease states of interest to the Menarini Group;
  • Knowledge of regulations in promotional conduct, safety reporting and deep understanding of the regional and local health environment including its structure, policy, reimbursement processes, key members and scientific societies;
  • Able to lead training initiatives and best practices.
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