Senior Manager, Global Medical Information

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 Alexions 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.

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 candidates skills and experience job-related knowledge and other specific business and organizational 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.