Manager, Global Medical Information & Medical Review

Introduction to role

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. This role is responsible for providing accurate, timely, balanced, and up-to-date medical and scientific information to internal and external customers globally. The Senior Manager will develop and maintain current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and patient outcomes associated with assigned Alexion products and disease states. Additionally, this individual may support broader activities in Medical Communications, including Medical Education and Scientific Communications. The employee carries out this role in accordance with departmental SOPs, corporate policy, and other legal and regulatory requirements.

Accountabilities

• 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.

• Researching the appropriate sources of data/information to provide a quick, accurate, and thorough response.

• Leading the development (research, outline, compose, review) and maintenance of standard and custom medical information responses in various formats to address a vast array of inquiries.

• Providing direction to third-party contact centers as it relates to compliance with workflow procedures and standards, inquiries requiring escalation or customization, corrections resulting from quality control/case review activities, and new hire or ongoing therapeutic area/product training as applicable.

• Proactively distributing important product and/or medical information to internal collaborators as necessary in support of product changes, safety issues, and other sentinel events.

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

• Supporting the generation of therapeutic area metrics and analytics; maintaining an in-depth understanding of historic trends and insights of inquiries received.

• Maintaining up-to-date medical information and knowledge management systems/repositories.

• Understanding and effectively applying/aligning with appropriate ethical, legal, and regulatory standards, including those for responding to unsolicited requests for information, on/off-label inquiries, and product promotion.

• Assisting in the development and delivery of various presentations to internal colleagues (e.g., medical information inquiry metrics and customer insights; training of commercial and medical field teams on medical information procedures; medical booth training at medical congresses).

• As applicable, potentially creating content for Medical Affairs and/or assisting in the review, fact-checking of data points, assessment of appropriateness of references cited in materials submitted to the Promotional and Medical Review Committees.

• May represent Medical comments in the Promotional and Medical Review Committees.

• As applicable, reporting any product quality complaints and adverse events to Quality Assurance/Drug Safety per corporate policies.

• As applicable, supporting various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; vendor oversight; etc.

• As applicable, providing support to broader activities in Medical Communications, including Medical Education and Scientific Communication.

Essential Skills/Experience

• Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) required

• Three 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.

• 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

• 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.

Desirable Skills/Experience

• 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 past experience in assigned therapeutic area(s) or rare disease, immunology, nephrology, hematology, oncology, neurology, enzyme-replacement therapies

• Experience working on product launches

• Completion of a PharmD post-doctoral fellowship in the pharmaceutical/biotech industy

At Alexion, AstraZeneca Rare Disease you will grow and innovate within a rapidly expanding portfolio. Enjoy the entrepreneurial spirit and autonomy of a leading biotech while being part of an energizing culture where people build connections to explore new ideas. As an important member of our commercial team, you'll meet the needs of some of the most under-served patients globally. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. Supported by exceptional leaders and peers ready to lift you in marketing, compliance, and beyond.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.