Hiring.Camp

Senior Manager, Global Medical Information and Medical Review

AstraZeneca

·

Yesterday

Location
Dublin, D,IE, IE
Type
Full-time
Department
Healthcare
Seniority
Senior
Experience
3+ years
Education
PhD
Source
Eightfold

Description

This is what you will do:

The Senior Manager of Global Medical Information and Medical Review will sustain and promote Alexion’s professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech industry by delivering high quality responses to unsolicited requests for information.

Additionally, the Senior Manager will drive excellence through focus on medical quality and standards, guiding applicable medical and marketing activities as part of the Global Promotional Review Committee (PRC) and Medical Review Committees (MRC).

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. As necessary, this individual may support broader activities in Medical Communications including Medical Education and Scientific Communications.

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

· Responsible for providing accurate, timely, balanced and up-to-date medical, scientific and regulatory guidance, review, advisement to support development of high quality promotional and medical materials as part of the Global PRC/MRCs.

· 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)

Global Medical Information

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

· Delivering high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.

· Supporting Alexion medical information booth activities both during preparation for and during professional scientific meetings / medical congresses.

You will need to have:

Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD, MSc) required with minimum 3 years of medical information or medical communications experience in the pharmaceutical/biotech industry, or completion of a PharmD post-doctoral fellowship in the pharmaceutical/ biotech industry.

· At least 1-year relevant experience in reviewing and approving local/regional promotional and/or nonpromotional materials.

· Demonstrated success in negotiating and influencing stakeholders

· Understanding of drug development, US (FDA)and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints

· Understanding of the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts

· Working knowledge of AI tools for Global Medical Information and Medical Review; ability to apply AI for literature review, content development, and summarization; and competency in evaluating AI outputs to ensure scientific accuracy, compliance, confidentiality, and adherence to company policies.

· Strong written and verbal communication skills

· Proficiency in literature searching skills

· Proficiency with Microsoft Office Suite

· Attention to detail

· Self-motivation to drive for results

· Excellent organizational, time management and prioritization skills

· Ability to travel to meetings / conferences (domestic and international) 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.

· 4+ years of medical information, medical review or medical communications experience in the pharmaceutical / biotech industry.

· Prior experience working with medical information systems/databases (e.g., IRMS) or promotional/medical review systems (e.g., Veeva PromoMats)

· Experience creating medical affairs content.

· Adept at learning new software / applications.

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

· Experience working on product launches.

· Completion of a PharmD post-doctoral fellowship in the pharmaceutical/biotech industry.

Date Posted

19-Aug-2026

Closing Date

01-Sept-2026

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.

Skills

FDACompliance

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