Associate Medical Director
Il y a 2 mois
Job Description
The Associate Medical affairs Director (AMD)
The AMD acts with an uncompromising commitment to patients and ensures the flawless execution of TA country medical plans, and is committed to:
- Develop and strengthen country medical affairs’ credibility within and outside of the organization.
- Provide fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex’ medicines in appropriate patients.
- Build trust through open and transparent collaboration with health care professionals and patient associations.
- Know the local health care system and keep up-dated on changes in environment in the country, including rules and regulations.
- Support as needed the execution of clinical development trials in the country.
Medical education:
- Provide fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex’ drugs in the appropriate patients.
- Internal (mainly marketing and sales functions) and external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products.
- Create, or co-create, and fully execute specific aspects of the Country Medical plan(s) agreed with the Therapeutic Area (TA) leads and Heamatology Medical Director
Key responsibilities:
- Demonstrate consistent ethical and professional behavior, with uncompromising commitment to patients.
- Build reputation and visibility of Vertex at the country level by providing fair and balanced medical information, communication, and education to various stakeholders, supporting research and relevant data generation with the goal of supporting the safe and effective use of Vertex' medicines in the appropriate patients.
Brand and Access support:
- Work in partnership with the Cross functional team (XFT) colleagues to ensure access to company’s products and develop and implement brand plans aligned with patient, HCPs’ and broader corporate needs.
- Reviewing and certification of promotional and non-promotional materials in the respective area according to the company SOP and to local country and regional regulations
- Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and marketed medicines.
External partnerships.
- Ensure excellent working partnerships are developed with Health Care Professionals (HCPs) based on scientific excellence and trust.
- Partner with HCPs to provide and obtain insights on therapeutic area issues and questions.
- Responsible for building and maintaining transparent and successful partnerships with national scientific societies, patient organizations, HTA bodies and relevant payers.
Cross
- funcional collaboration:
- Work closely with internal and key external stakeholders supporting Vertex’ strategy and bringing medical insights as well as support for media, government, and patient group activities, including policy development, corporate initiatives, and issues management.
- Strategic alignment of the HEME program working cross functionally and partnering with other key functions at Vertex such as Commercial, Regulatory, Market Access, HEOR, and Corporate Communications
- Accountable for supporting the Heamatology MD in the development, implementation and execution of the Medical Affairs Strategy and plan for pipeline and in market products.
Compliance and Pharmacovigilance:
- Ensure compliance of medical activities at country level with the Code of Conduct, local rules and regulations, company policies, SOPs, GCP, ICH and regulations the Charter of information and HAS Guidelines.
- Assess local promotional materials and ensure that all claims are fully supported by scientific data, and are presented in an accurate, fair, and balanced manner.
- Ensure self and other country medical staff have the required skills to identify AEs and assess causality of PV cases.
Other Medical activities:
- Ensures appropriate and adequate implementation of early access and compassionate use programs in country.
- Participates in the development of Life Cycle Management (LCM) Plans
- Drive data generation studies/projects to enhance medical-scientific knowledge in the Therapeutic Area(s) and Ensures implementation of RWD initiatives and LCM plans in country, as appropriate.
- Ensures medical team supports Investigator Initiated research aligned with strategic areas of interest and in a compliant fashion.
- Review clinical trials and community-based grant requests, as needed.
- Ensures appropriate Steering Committee meetings and advisory boards are held in accordance with local and company regulations. As appropriate leads such initiatives
Key requirements:
- Medical doctor (MBChB/MBBS/MD) preferred, or PhD (in relevant scientific field)
- Experience in Hematology, Cell and Gene Therapy or o
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