Director, Global Medical Information and Medical Review

This is what you will do:

The Director of Global Medical Information and Medical Review leads the development and transfer of intellectual capital that maximizes the safe and appropriate use of Alexion products to healthcare professionals and patients world-wide. This person is accountable for the execution of medical information and medical review activities for assigned therapeutic area(s), as well as contributes and implements department strategic imperatives and objectives. The Director is accountable for aligning global medical information pre- and post-launch plans with internal constituents in Medical Affairs, Commercial, and Clinical Development Teams. Success of this individual is highly dependent on the ability to collaborate cross-functionally and understand business strategy.

In addition, the Director will apply medical governance and drive excellence through focus on medical quality and standards, guiding applicable marketing and medical activities to be undertaken in a compliant and ethical manner. The Director will provide essential medical, scientific and regulatory expertise, review, advisement and oversight to support development of high quality promotional and medical materials as part of the Global Promotional Review Committee (PRC) and Medical Material Review (MMR) Committee.

The employee carries out this role in accordance with Company Standards/SOPs, regulatory requirements and applicable external codes including the IFPMA and EFPIA codes of practice.

You will be responsible for:

Global Medical Information

· Developing / maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.

· Leading planning, prioritization, and execution in alignment with internal stakeholders (e.g., Global Medical Affairs, Commercial, Clinical Development), ensuring product launch preparedness in the dissemination of medical information.

· Leading the development, review and approval of medically accurate, up-to-date, and timely intellectual capital (e.g., medical information response documents, frequently asked questions) addressing the global scientific community’s knowledge gaps in disease / diagnosis, product information and clinical data in order to ensure consistency in scientific exchange by world-wide Medical Affairs personnel in a compliant manner.

· Training and mentoring Associate Directors, Managers, Fellows and third-party contact center team to ensure alignment with operational objectives, excellence in execution, and maintenance of quality performance.

· Overseeing / leading medical information booth activities on behalf of medical personnel at professional scientific meetings; including ensuring adequate staffing levels, medical information resources are in-date, cross-functional colleagues are trained, and post-congress reports are completed within a timely manner.

· Providing responses to unsolicited requests for medical information.

Global Medical Review and Approval of Promotional/Non-Promotional Materials/Activities

· Acting as the lead reviewer and Alexion authority, responsible for the review and approval of global promotional and nonpromotional materials/activities within assigned therapeutic area(s).

· The reviewer will apply medical governance and drive excellence through focus on medical quality and standards ensuring that marketing and medical materials adhere to Company standards and external regulations pertaining to prescription drug advertising and promotion, as applicable.

· Providing medical, scientific and regulatory guidance to commercial teams for appropriate disease and product claims development; ensuring that information presented in materials are medically and scientifically accurate, meet the relevant substantiation standards and are consistent with the product label.

· Collaborate with Global Medical Affairs Leads and Medical Directors to ensure nonpromotional materials are aligned to medical strategy.

· Providing mentorship on ethical, legal and regulatory standards for product promotion and scientific exchange.

· Developing / maintaining current, broad, and in-depth knowledge of regulatory and advertising compliance requirements / limitations as applicable to promotional and non-promotional materials.

· Supporting and collaborating with the local Alexion medical and regulatory reviewers who undertake final approval of materials according to their local regulatory jurisdiction.

· Assisting in the development / maintenance of departmental Policies, Standard Operating Procedures (SOPs), WPDs (Working Practice Documents), and Work Instructions (WIs).

You will need to have:

· Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD, MSc) with 7 years of medical information or medical communications experience in the pharmaceutical / biotech industry.

· At least 5 years relevant experience in reviewing and approving local/regional promotional and/or nonpromotional materials.

· Thorough knowledge of regulatory and compliance requirements / limitations applicable to medical information.

· Experience leading medical information or medical communication initiatives for a product launch.

· Sound knowledge of international medical compliance legislation, codes of practice and their practical application to advertising and promotional materials.

· High ethical standards. An understanding of ethical decision-making processes and an ability to discuss ethical and regulatory issues with credibility and authority as they relate to risk assessment.

· Experience in developing work practice documents, SOPs and effective training materials.

· Excellent written and verbal communication skills.

· Demonstrated ability to achieve aligned objectives in a matrixed environment.

· Team player in a multidisciplinary, cross-cultural environment, high level of flexibility.

· Strong skills in project planning, courageous/challenging decision-making, problem-solving, and negotiating towards mutually beneficial outcomes.

· Highly proficient with Microsoft Office Suite.

· Ability to travel to meetings / conferences (including internationally) approximately 20% of the time.

· The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

· Experience providing medical information/medical communication support within a Global function.

· 10 years of relevant experience in reviewing promotional or scientific materials.

· Sound knowledge of UK ABPI code of practice.

· 3 years of formal management experience.

· Experience developing (or overseeing the development of) materials utilized by Medical Affairs in the context of scientific exchange.

· Training or experience in assigned therapeutic area(s) or rare disease.

· Demonstrated project management skills.

Date Posted

24-Nov-2025

Closing Date

07-Dec-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.