Associate Director, Global Medical Information and Medical Review
This is what you will do:
The Associate Director of Global Medical Information and Medical Review is responsible for managing Global Medical Information service functions within a given therapeutic area (TA), including but not limited to the medical review of promotional and scientific materials, and planning and implementation of medical information deliverables within set timelines via oversight of more junior staff and/or vendors. This role is responsible for developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states. As the TA representative for Global Medical Information and Medical Review, this advanced level of knowledge and awareness of Global medical inquiry trends are used to effectively influence strategic decision making in collaboration with other cross-functional team members.
In addition, the Associate 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 Associate Director will provide essential medical, scientific and regulatory guidance, 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
· Maintaining an advanced level of therapeutic knowledge (clinical and theoretical) of pathophysiology, diagnosis, drug therapy, standards of care, competitive landscape and desired patient outcomes in assigned therapeutic Area (TA).
· Delivering high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.
· Serving as the Global Medical Information and Medical Review expert in the given therapeutic area(s) (TA) and as the escalation point for triage of complex inquiries from junior team members; provides guidance to junior team members as needed.
· Developing a strategy, prioritization and project plan for the development / maintenance and review / approval for global medical information response documents.
· Autonomously planning and facilitating disease, product, response document and process-related training of medical information contact center associates.
· Leading / directing 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.
· Proactively distributing important product and/or medical information to relevant internal Medical Affairs functions as necessary in support of product changes, safety issues and other sentinel events; enhances medical and product knowledge within the Sales Force, Marketing, Field Medical and other departments by disseminating relevant information on a consistent basis, as needed.
· Systematically compiling / assessing / maintaining / communicating insights and metrics that monitor Medical Information trends. Has a detailed and in-depth understanding of historic trends and insights and is able to apply these analytics to the medical plan.
Global Medical Review and Approval of Promotional/Non-Promotional Materials/Activities
· Acting as the 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.
· 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 minimum 5 years medical information, medical affairs or relevant experience in the pharmaceutical / biotech industry.
· At least 3 years of relevant experience in reviewing and approving local/regional promotional and/or nonpromotional materials.
· Experience with drug development, health authority regulations and reporting requirements.
· Experience with the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts.
· Proficiency in collaboration, negotiating and influencing skills.
· Excellent written and verbal communication skills.
· High proficiency in literature searching skills.
· High degree of detail-orientation in the development and review of medical information response documents.
· Self-motivation to drive for results, with strong organizational and planning skills.
· High proficiency with Microsoft Office Suite.
· Ability to travel to meetings / conferences (domestic and international) approximately 10% 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 Global medical information/medical communication support within a Global function.
· 7 years of relevant experience in reviewing promotional or scientific materials.
· Experience reviewing and approving Global promotional and nonpromotional materials.
· Experience developing (or overseeing the development of) materials utilized by Medical Affairs in the context of scientific exchange.
· Experience leading medical information or medical review initiatives for a product launch.
· Training or past experience in assigned therapeutic area(s) or rare-disease.
· Demonstrated project management skills.
Date Posted
31-Mar-2026Closing Date
14-Apr-2026Our 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.