Alexion Pharmaceuticals, Inc.
The Associate Director of Global Medical Information and Medical Review is responsible for managing all US and Global Medical Information service functions within a given therapeutic area, 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. 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. 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 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.
Delivers high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.
Develops / maintains current, broad, and in –depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
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.
Possesses an advanced level of therapeutic knowledge (clinical and theoretical) of pathophysiology, diagnosis, drug therapy, and desired patient outcomes. 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, congress planning meetings, publication team meetings, and other Medical Affairs meetings within the assigned TA of expertise.
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 and oversight to commercial teams for appropriate disease and product claims development.
Collaborates with Global Medical Affairs Leads and Regional Medical Directors to develop a strategy, prioritization and project plan for the development /maintenance and review / approval for global medical 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.
Provides support to broader activities in Medical Communications as necessary, including Medical Education and Scientific Communications.
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 5 years' medical information or medical communications experience in the pharmaceutical / biotech industry
Demonstrated project management skills (1-2 years)
Understands drug development, health authority regulations and reporting requirements for adverse events and medical communications
Understands the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts
Highly proficient in literature searching skills
Highly detail-oriented in the development and review of medical information response documents
Excellent written and verbal communication skills
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 20% of the time
medical information/medical communication support
2 years' of relevant experience in review / editing promotional materials
1 year of formal management experience
Experience leading medical information initiatives for a product launch
Training or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies
Experience in developing work practice documents, SOPs and effective training materials
Prior experience working with medical information or medical communication systems / databases
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com
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Alexion is an Equal Opportunity /Affirmative action employer
Boston, MA, US
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Alexion Pharmaceuticals, Inc.
Website : http://www.alexion.com
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with severe and life-threatening diseases that are also ultra-rare. Patients with these devastating diseases often have no effective treatment options, and they and their families suffer with little hope.