The Director of Global Medical Information and Medical Review leads the development and transfer of intellectual capital that maximizes the safe and appropriate use of Alexion products to healthcare professionals and patients world-wide. This person is accountable for developing strategies, establishing objectives, and overseeing the execution of global medical information and medical review activities for assigned therapeutic area(s). This includes aligning global medical information pre- and post-launch plans with internal constituents in Global Medical Affairs, Global Commercial Teams, and Global Clinical Development Teams. The Director is accountable for leading a team and establishing/maintaining operations and infrastructure to support the development and dissemination of medical information globally.
In addition, the Director will provide essential medical and scientific expertise, review, advisement and oversight to support development of high quality promotional and medical materials, internal training materials, and communications as part of the Medical / Legal / Regulatory (MLR) Review Committee.
The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.
Direct Reports: Associate Directors and Sr / Managers in Global Medical Information and Medical Review.
Provides strategic planning, prioritization, and execution in alignment with internal stakeholders (Global Medical Affairs, Global Commercial, Global Clinical Development) to ensure product launch preparedness in the global dissemination of medical information.
Develops / maintains current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
Oversees the development, review and approval of medically accurate, up-to-date, and timely intellectual capital (e.g., medical information response documents, frequently asked questions) addressing the global scientific community's knowledge gaps in disease / diagnosis, product information and clinical data in order to ensure consistency in scientific exchange by US and worldwide Medical Affairs personnel in a compliant manner.
Leads (builds as necessary) a high-functioning medical information / medical review team to support assigned therapeutic areas. Manage, train and mentor Associate Directors, Managers, Fellows and third party contact center team to ensure alignment with operational objectives, excellence in execution, and maintenance of quality performance. Provide mentorship to direct reports to support their professional and personal development.
As a member of the Global Medical Affairs Team (GMAT), contributes to the development and implementation of the Brand Medical Plan.
Represents medical function in the MLR Review Committee and ensures scientific / medical / clinical accuracy, relevance and completeness of data and that promotional claims within materials are adequately supported by data.
Provides medical / scientific expertise and oversight to commercial teams for appropriate disease and product claims development.
Understands, effectively applies and ensures team complies with appropriate ethical, legal and regulatory standards, including those for product promotion and for responding to unsolicited requests for on/off label inquiries.
Ensures compliance with internal audit and Health Authority / regulatory document requirements.
Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) with 7 years of medical information or medical communications experience in the pharmaceutical / biotech industry
3 years of formal management experience
3 years of experience in reviewing promotional materials
Thorough knowledge of the regulatory and compliance requirements / limitations applicable to medical information, as well as promotional and non-promotional pharmaceutical materials
Experience leading medical information or medical communication initiatives for a product launch
Experience in developing work practice documents, SOPs and effective training materials
Excellent written and verbal communication skills
Strong skills in project planning, courageous/challenging decision-making, problem-solving, and negotiating towards mutually beneficial outcomes
Highly proficient with Microsoft Office Suite
Ability to travel to meetings / conferences (including internationally) approximately 20% of the time
Experience providing medical information/medical communication support within a Global function
5 years of relevant experience in review/editing promotional materials
5 years of formal management experience
Training or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies
Team player in a multidisciplinary, cross-cultural environment, high level of flexibility
Experience managing capital and operational budgets
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.