When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Introduction to the role:

The Senior Manager of Global Medical Information and Medical Review will maintain Alexion’s professional reputation and integrity with patients, health care professionals, and the pharmaceutical and biotech industry. They will do this by providing high quality responses to unsolicited information inquiries.

This role is responsible for developing and sustaining up-to-date, extensive, and detailed 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.

Key Responsibilities:

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.
• Researching the appropriate sources of data/information to provide a quick, accurate and thorough response.
• Leading the development (research, outline, compose, review) along with upkeep of standard and custom medical information responses in various formats to address vast array of inquiries.
• Providing direction to third party contact center as it relates to
• Compliance with workflow procedures and standards
• Inquiries requiring escalation or customization
• Corrections resulting from quality control / case review activities
• New hire or ongoing therapeutic area/product training, as applicable
• Proactively distributing important product and / or medical information to internal partners 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 in-depth understanding of historic trends and insights of inquiries received.
• Maintaining up-to-date clinical data and knowledge management systems / repositories
• Understanding and effectively applying/complying with appropriate ethical, legal, and regulatory standards, including those for responding to unsolicited requests for information, on / off label inquiries, and product promotion.
• Supporting the creation and delivery of presentations to internal colleagues. This involves sharing medical information inquiry metrics, customer insights, and training commercial and medical field teams on procedures. It also includes 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.
• As applicable, providing support to the medical review and approval of promotional and non-promotional materials.

Essential Qualifications:

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 non promotional materials.
• Proven success in negotiating and influencing partners
• Understanding of drug development, US (FDA) and global (e.g. EMEA) regulations and reporting requirements for pharmacovigilance events and product quality concerns
• 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 work towards 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.

Preferred Qualifications:

• 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.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

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AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.