Associate Director, International Medical Review

hace 3 semanas

Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Location: Barcelona, Spain

Job reference: R-198734

Date posted: 05/02/2024

**Position Summary**

The International Medical Review Lead reports into the Sr. Director Global Medical Information and Medical Review (GMI-MR) and is responsible for leading the Medical Review function as part of the Medical, Legal, and Regulatory (MLR) review committee. This individual serves as the Medical delegate, ensuring medical accuracy and medical veracity of promotional and non-promotional materials. The International Medical Review Lead will liaise with functional leaders to operationalize robust and compliant procedures for the MLR review process.

Additionally, the individual in this role serves as the departmental liaison between headquarters-based Global Medical Information and local countries in the provision of the medical information service in the International region. This includes overseeing service operations in these regions as it pertains to ensuring the provision of high quality, timely, medical information and technical information/specifications, on request, to external [Physicians, Nurses, Pharmacists, other Health Care Professionals (HCPs), patients, caregivers and other], and internal stakeholders either directly or through contracted medical information service providers/contact centers.

The employee carries out this role by developing an expert understanding of product data and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics across Alexion’s therapeutic areas.

The position requires a high level of expertise in the disciplines of medical review and medial information, scientific acumen, and cross-functional collaboration, including working closely with GMI-MR team members, as well as regional Medical Affairs, Commercial, Legal, Regulatory, Quality, and Drug Safety. Excellent oral and written communication skills, customer focus, and teamwork are essential for this role. Previous participation in audits is a plus.

Direct Reports: External consultants / vendor currently.

**Principal Responsibilities**

**Medical Review**
- Works collaboratively and develops good working relationships with the Global Medical Affairs Lead (GMALs) and Medical Directors to ensure alignment of company medical strategy. This includes escalating materials accordingly when guidance is required.
- Serves as the medical delegate on International Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review and approval of all promotional and medical/scientific materials containing information on Alexion’s marketed products and compounds in development, as well as the corresponding disease states developed for International markets.
- Reviews materials and ensures data included are accurate, within context, and presented in a fair/scientifically balanced manner. Verifies the substantiation of all claims and comparisons. Determines acceptability of references, advises on whether claims are consistent with appropriate approved label, and ensures that the piece is relevant and of utility for the target audience.
- Oversees and manages external consultants who support Medical Review in the International MLR function.
- Participates and actively contributes in key strategic meetings led by marketing, regulatory or access and ensures early sharing of medical content as per MLR guidance.
- Advises on materials and events designed and produced by International Marketing and Medical Affairs teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions.
- Supports International Marketing and Global Medical Directors through guidance and provision of information on company products, brand messages and claims that are in compliance with regulatory requirements and applicable external codes of practice, including but not limited to the EFPIA (European Federation Pharmaceutical Industries and Associations) and IFPMA (International Federation of Pharmaceutical Manufacturers) codes.
- Ensures standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate use of products.

**Medical Information**
- Assists Global Medical Information in identifying regional medical information needs per country and working in collaboration with those affiliates to optimize delivery of MI service:

- Assist Global team in handling call center vendor escalations of medical information inquiries
- Maintain and update the Medical Information Letter Library in accordance with label updates, as requested by the Global Medical Information Therapeutic Area teams
- Establish and/or maintain applicable regional and/or local MI procedural documents in alignment with other local and global SOPs
- Responsible for oversight of language translation requirements of documents per company or local

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