Alexion Pharmaceuticals Associate Director, GMI & Medical Review in Boston, Massachusetts
This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA, and may require up to 20% travel.
The Associate Director of Global Medical Information and Medical Review is responsible for managing US and Global Medical Information service functions within a given therapeutic area (TA), including but not limited to the medical review of promotional and scientific materials, and planning and implementation of medical information deliverables within set timelines via oversight of more junior staff and/or vendors. This role is responsible for developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states. As the TA representative for Global Medical Information and Medical Review, this advanced level of knowledge and awareness of US / Global medical inquiry trends are used to effectively influence strategic decision making in cross-functional meetings including but not limited to Medical / Legal / Regulatory (MLR) Committee Review meetings (eg., Promotional Review Committee [PRC] or Medical Review Committee [MRC], congress planning meetings, publication team meetings, and other Medical Affairs meetings within the assigned TA of expertise. In addition, the Associate Director is responsible for providing accurate, timely, balanced and up-to-date medical and scientific information to internal and external customers, globally.
The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.
Direct Reports: None.
Represents medical function in the MLR Review Committee and ensures scientific / medical / clinical accuracy, relevance and completeness of data, appropriateness of references cited and that promotional claims within materials are adequately supported by data.
Provides medical / scientific expertise to commercial teams for appropriate disease and product claims development.
Collaborates with US and Global Medical Affairs Leads and Medical Directors to ensure promotional and non-promotional materials are aligned to medical strategy
Maintains an advanced level of therapeutic knowledge (clinical and theoretical) of pathophysiology, diagnosis, drug therapy, standards of care, competitive landscape and desired patient outcomes in assigned therapeutic Area (TA).
Delivers high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.
Serves as the Global Medical Information and Medical Review expert in the given therapeutic area(s) (TA) and as the escalation point for triage of complex inquiries from junior team members; provides guidance to junior team members as needed.
Develop a strategy, prioritization and project plan for the development / maintenance and review / approval for global medical information response documents.
Autonomously plans and facilitates disease, product, response document and process-related training of medical information contact center associates.
Leads / directs medical information booth activities on behalf of medical personnel at professional scientific meetings; including ensuring adequate staffing levels, medical information resources are in-date, cross-functional colleagues are trained and post-congress reports are completed within a timely manner.
Proactively distributes important product and/or medical information to relevant internal Medical Affairs functions as necessary in support of product changes, safety issues and other sentinel events; enhances medical and product knowledge within the Sales Force, Marketing, Field Medical and other departments by disseminating relevant information on a consistent basis, as needed.
Systematically compiles / assesses / maintains / communicates metrics that monitor Medical Information trends. Has a detailed and in-depth understanding of historic trends and insights and is able to apply these analytics to the medical plan.
Achieves and maintains compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Alexion are carried out with the best industry practices and the highest ethical standards.
Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) with minimum 5 years medical information, medical affairs or relevant experience in the pharmaceutical / biotech industry
3 years of relevant experience in reviewing and approving US promotional and/or non-promotional materials
Understands drug development, health authority regulations and reporting requirements
Understands the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts
Proficient in collaboration, negotiating and influencing skills
Excellent written and verbal communication skills
Highly proficient in literature searching skills
Highly detail-oriented in the development and review of medical information response documents
Self-motivated to drive for results, with strong organizational and planning skills
Highly proficient with Microsoft Office Suite
Ability to travel to meetings / conferences (domestic and international) approximately 10% of the time
Experience providing Global medical information/medical communication support within a Global function
Experience reviewing and approving Global promotional and non-promotional materials
Experience leading medical information or medical review initiatives for a product launch
Training or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies
Demonstrated project management skills
People management experience
Prior experience working with medical information or medical communication systems / databases
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 and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 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) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. 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, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. 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.