Senior Manager, Global Medical Information & Medical Review

Alexion Pharmaceuticals, Inc. Boston , MA 02298

Posted 3 months ago

Position Summary

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.

Principal Responsibilities

  • 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.

Essential Qualifications

  • 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

  • Detail-oriented

  • 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

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

  • 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

  • LI-MW1

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.


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VIEW JOBS 11/5/2019 12:00:00 AM 2020-02-03T00:00 Position Summary 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. Principal Responsibilities * 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. Essential Qualifications * 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 Preferred Qualifications * Experience providing Global 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 * LI-MW1 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. Boston MA

Senior Manager, Global Medical Information & Medical Review

Alexion Pharmaceuticals, Inc.