The Sr. 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. The Sr. Manager is responsible for providing accurate, timely, balanced and up-to-date medical and scientific information to internal and external customers, globally. 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 departmental SOPs, corporate policy and other legal and regulatory requirements.
Direct Reports: None.
Develops / maintains current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
Delivers high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.
Researches the appropriate sources of data/information to provide a quick, accurate and thorough response.
Leads the development (research, outline, compose, review) and maintenance of standard and custom medical information responses in various formats to address vast array of inquiries.
Assists 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
Provides 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 distributes important product and / or medical information to internal stakeholders as necessary in support of product changes, safety issues and other sentinel events.
Supports Alexion medical information booth activities both during preparation for and during professional scientific meetings / medical congresses.
Supports the generation of therapeutic area metrics and analytics; maintains in-depth understanding of historic trends and insights of inquiries received.
Maintains up-to-date medical information and knowledge management systems / repositories
Understands and effectively applies and complies with appropriate ethical, legal and regulatory standards, including those for responding to unsolicited requests for information, on / off label inquiries, and product promotion.
Assists 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, reports any product quality complaints and adverse events to Quality Assurance / Drug Safety per corporate policies.
As applicable, supports various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; vendor oversight; etc.
As applicable, provides support to broader activities in Medical Communications, including Medical Education and Scientific Communication.
Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) required with 3 years of medical information or medical communications experience in the pharmaceutical/biotech industry
Demonstrated success in negotiating and influencing stakeholders
Understands drug development, US (FDA) and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints
Understands 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
Proficient in literature searching skills
Proficiency with Microsoft Office Suite
Self-motivated 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
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
Completion of a post-PharmD Fellowship 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)
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
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.