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Associate Director, Global Medical Information And Medical Review
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 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 Material Review [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 Committee Review meetings 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 non-promotional materials are aligned to medical strategyMaintaining 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 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 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.The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, 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.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 industry3 years of relevant experience in reviewing and approving US promotional and/or nonpromotional materialsExperience with drug development, health authority regulations and reporting requirementsExperience with the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstractsProficient in collaboration, negotiating and influencing skillsExcellent written and verbal communication skillsHighly proficient in literature searching skillsHighly detail-oriented in the development and review of medical information response documentsSelf-motivated to drive for results, with strong organizational and planning skillsHighly proficient with Microsoft Office SuiteAbility to travel to meetings / conferences (domestic and international) approximately 10% of the timeThe duties of this role are generally conducted in an office environment.
As is typical of an office-based role, 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.We would prefer for you to have:Experience providingGlobalmedical information/medical communication support within aGlobalfunctionExperience reviewing and approvingGlobalpromotional and nonpromotional materialsExperience developing (or overseeing the development of) materials utilized by Medical Affairs in the context of scientific exchangeExperience leading medical information or medical review initiatives for a product launchTraining or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapiesDemonstrated project management skillsPeople management experiencePrior experience working with medical information or medical communication systems / databasesAstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.#J-18808-Ljbffr
