Associate Director, International Medical Review And Medical Information Lead
hace 2 meses
This is what you will do: The Associate Director of Global Medical Information and Medical Review is responsible for managing 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 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 Materials Review Committee [MMR]), 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.
You will be responsible for: Representing medical function in the MLR Review Committees and ensuring scientific / medical / clinical accuracy, relevance and completeness of data, appropriateness of references cited and that promotional claims within materials are adequately supported by data.Providing medical / scientific expertise to commercial teams for appropriate disease and product claims development.Collaborating with Global Medical Affairs Leads and Medical Directors to ensure promotional and nonpromotional materials are aligned to medical strategy.Maintaining 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).Delivering high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.Serving 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.Developing a strategy, prioritization and project plan for the development / maintenance and review / approval for global medical information response documents.Autonomously planning and facilitating disease, product, response document and process-related training of medical information contact center associates.Leading / directing 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 distributing 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 compiling / assessing / maintaining / communicating insights and 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.Achieving and maintaining 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.You will need to have: 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 local/regional promotional and/or nonpromotional materials.Experience with drug development, health authority regulations and reporting requirements.Experience with the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts.Proficiency in collaboration, negotiating and influencing skills.Excellent written and verbal communication skills.High proficiency in literature searching skills.High degree of detail-orientation in the development and review of medical information response documents.Self-motivation to drive for results, with strong organizational and planning skills.High proficiency with Microsoft Office Suite.Ability to travel to meetings / conferences (domestic and international) approximately 10% of the time.We would prefer for you to have: Experience providing Global medical information/medical communication support within a Global function.Experience reviewing and approving Global promotional and nonpromotional materials.Experience developing (or overseeing the development of) materials utilized by Medical Affairs in the context of scientific exchange.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.Prior experience working with medical information or medical communication systems / databases.
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