Director, Global Medical Information and Medical Review 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 for healthcare professionals and patients worldwide.
This individual is accountable for executing medical information and medical review activities for assigned therapeutic areas, and for contributing to and implementing departmental strategic imperatives and objectives.
The Director aligns global medical information pre‑ and post‑launch plans with internal constituents in Medical Affairs, Commercial, and Clinical Development Teams, and collaborates cross‑functionally to understand business strategy.
Additionally, the Director applies medical governance to drive excellence by focusing on medical quality and standards, guiding marketing and medical activities to be compliant and ethical.
The Director provides essential medical, scientific, and regulatory expertise, review, advisement, and oversight to support the development of high‑quality promotional and medical materials as part of the Global Promotional Review Committee (PRC) and Medical Material Review (MMR) Committee.
Global Medical Information Developing and maintaining current, broad, and in‑depth knowledge of the pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
Leading planning, prioritization, and execution in alignment with internal stakeholders to ensure 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, FAQs) addressing the global scientific community's knowledge gaps in disease/diagnosis, product information, and clinical data.
Training and mentoring Associate Directors, Managers, Fellows, and third‑party contact center team to align with operational objectives, execution excellence, and quality performance.
Overseeing and leading medical information booth activities on behalf of medical personnel at professional scientific meetings; ensuring adequate staffing, up‑to‑date resources, trained colleagues, and timely post‑conference reports.
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 non‑promotional materials/activities within assigned therapeutic areas.
Applying medical governance to ensure marketing and medical materials adhere to company standards and external regulations related to prescription drug advertising and promotion.
Providing medical, scientific, and regulatory guidance to commercial teams for appropriate disease and product claims; ensuring information in materials is medically and scientifically accurate, meets substantiation standards, and is consistent with the product label.
Collaborating with Global Medical Affairs Leads and Medical Directors to align non‑promotional materials with medical strategy.
Providing mentorship on ethical, legal, and regulatory standards for product promotion and scientific exchange.
Developing and maintaining current, broad, and in‑depth knowledge of regulatory and advertising compliance requirements/limitations applicable to promotional and non‑promotional materials.
Supporting and collaborating with 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), working practice documents (WPDs), and work instructions (WIs).
Qualifications Advanced scientific degree in pharmacy (Pharm D) or related science (Ph D, MD, MSc) with at least 7 years of medical information or medical communications experience in the pharmaceutical/biotech industry.
At least 5 years of relevant experience reviewing and approving local/regional promotional and/or non‑promotional 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 ability to discuss ethical and regulatory issues with credibility and authority as they relate to risk assessment.
Experience 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 with high flexibility.
Strong skills in project planning, challenging decision‑making, problem‑solving, and negotiation toward mutually beneficial outcomes.
Highly proficient with Microsoft Office Suite.
Ability to travel to meetings/conferences (including internationally) approximately 20% of the time.
General office‑environment duties: use a computer; engage in communications via phone, video, and electronic messaging; problem‑solve; collaborate; maintain general availability during standard business hours.
Preferred Qualifications Experience providing medical information/medical communication support within a global function.10 years of relevant experience reviewing promotional or scientific materials.
Sound knowledge of UK ABPI code of practice.
Formal management experience of at least 3 years.
Experience developing or overseeing the development of materials utilized by Medical Affairs for scientific exchange.
Training or experience in assigned therapeutic area(s) or rare disease.
Demonstrated project management skills.
Other Information Date Posted: 16-Dec-2025 Closing Date: 15-Jan-2026 Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at Astra Zeneca 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 perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
#J-18808-Ljbffr