Senior Manager, US Medical Review

AstraZeneca•Boston, MA

11d•$116,710 - $175,064•Onsite

About The Position

The Senior Manager, US Medical Review will sustain and promote Alexion’s professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech industry by providing high quality Medical Review of all material used by the Commercial and Medical teams. 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.

Requirements

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.
Understanding of drug development, US (FDA)and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints
Strong written and verbal communication skills
Proficiency in literature searching skills.
Proficiency with Microsoft Office Suite
Attention to detail.
Self-motivation to drive for results.
Excellent organizational, time management and prioritization skills
Employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Nice To Haves

2+ years of experience providing medical review as part of an MLR team.
5+ -years of relevant experience in academia and/or pharmaceutical/biotech industry. Or 2-years of relevant experience in pharmaceutical/biotech industry.
Prior experience working with promotional/medical review systems (e.g., Veeva PromoMats)
Experience creating medical affairs content.
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.
Completion of a post-PharmD Fellowship in the pharmaceutical/biotech industry

Responsibilities

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 Promotional Review Committee (PRC) and Medical Review Committee (MRC).
Developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
Supporting the generation of therapeutic area metrics and analytics to aid in load management and forecasting future resources.
Assisting 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, potentially creating content for Medical Affairs and/or assisting in the review, fact-checking of data points, assessment of appropriateness of references cited in materials submitted to the Promotional and Medical Review Committees
As applicable, reporting any product quality complaints and adverse events to Quality Assurance / Drug Safety per corporate policies.
As applicable, supporting various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; vendor oversight; etc.
As applicable, providing support to broader activities in Medical Communications, including Medical Education and Scientific Communication.