Senior Manager, Global Medical, Legal, Regulatory Review

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The Senior Manager, Global Medical/Legal/Regulatory (MLR) Review is a central member of the Global MLR Review team responsible for the global review and approval of promotional and non-promotional materials. This role is responsible for developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and patient outcomes associated with assigned Alexion products and disease states. This role will initially focus as the Regulatory reviewer on the MLR team to ensure specified materials and activities linked to promotion meet external regulations, industry code of practice standards (EFPIA/IFPMA) and Company policies. As this individual becomes more of a subject matter expert, they may also supply to review of medical accuracy. This individual will also liaise with the final signatories of materials at country-level company affiliates to promote best practices and provide support on regulatory issues concerning promotional materials. The Senior Manager will engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review, and approval of promotional materials.

YOU WILL BE RESPONSIBLE FOR:

• Serve as primary advertising and promotional compliance contact within assigned therapy area(s), responsible for the global review and approval of promotional and non-promotional materials / activities including disease awareness, medical materials etc.
• Developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
• In close collaboration with Medical Affairs, participate in concept review meetings to provide regulatory guidance to Project Owners responsible for the generation and distribution of materials.
• Ensure promotional and non-promotional materials are in compliance with global standards and external regulations pertaining to prescription drug advertising and promotion, as applicable.
• In collaboration with their manager in the Global Advertising and Promotional Compliance group, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products.
• As needed, provide training support within Alexion on requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
• In collaboration with the Global Advertising and Promotional Compliance group, participate in developing processes and procedures relevant to the creation, review, and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products.
• Ensure stakeholder awareness of proposed and newly approved labeling changes in EU region.