Global Medical Affairs Manager/Sr. Manager

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:? Provides scientific/medical review and approval (as appropriate) of promotional materials and activities in accordance with pharmaceutical regulations, guidelines, codes of practice and Shire policies and processes for approved products and/or products in development within a specific business unit (ADHD, GI, Renal) or region.? Provides review of concepts and materials for activities such as advisory boards, consultants meetings, medical education programs and use by internal personnel (eg, Medical Science Liaisons).? Maintains a high level of technical expertise through familiarity with medical and scientific literature for an assigned therapeutic area.? May lead publication strategy teams for assigned products/therapy areas? May participate in project strategy teams and advisory panels.Strategic Management (20%)? Collaborates with Medical Affairs and business unit colleagues in the development of promotional messages and evaluation of appropriate supportive documentation for promotional material and product labeling within assigned therapeutic area.? As applicable, develops and implements global scientific publication plan (strategy and tactical activities) for specific project/product. ? May participate in brand team and commercial activities including the evolution of brand positioning and life cycle strategies.Operational Management (60%)? Reviews and approves (as appropriate) content of promotional materials to ensure information, claims and comparisons are medically and scientifically accurate, clinically relevant, presented in appropriate context and are in accordance with regulations, guidelines, codes of practice and Shire policies and procedures.? Reviews accuracy of medical and scientific content of materials presented at Shire sponsored consultant meetings and advisory boards.? Provides support for the development of and review and approval of presentation materials (eg, slides) related to Shire products and therapeutic areas.? Develops, conducts, or participates in training programs for Shire internal departments, for example, Global Medical Affairs (GMA), Business Unit teams and vendors to ensure compliance with Shire policies, guidelines and processes.? Establishes and maintains strong relationships with internal and external partners to support comprehensive and efficient reviews.? Participates in national and international meetings on behalf of Shire for educational and intelligence gathering purposes.? Manages access and updates to documentations used to support product claims for assigned products.? Contributes to internal policy and procedure development and process improvement activities.? May implement global publications/communications plan for specific project/product, in line with the roles and responsibilities defined for the Project Team within the Shire Operating Model.? May be responsible for financial planning and budgetary adherence of medical affairs support requirements within assigned therapeutic area.? May supervise medical affairs professionals and administrative staff.Maintenance of Knowledge Base/Leadership Potential (20%)? Maintains updated knowledge of all current global pharmaceutical regulations, guidelines, codes of practices and Shire policies related to promotional materials and activities and educational programs.? Develops and maintains scientific expertise and familiarity with literature regarding products, including competitor actions, and evolution of promotional practice needs.? Participates in activities managed by professional organizations (eg, DIA) and other outside parties (eg, CROs, vendors) in line with professional personal development objectives.? Identify opportunities to enhance and strengthen personal leadership skills in line with the Shire Leadership DNA.Education & Experience RequirementsInclude educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred. ? Incumbent is responsible for determining appropriateness of documentation for promotional materials and requesting revisions to materials.? Incumbent has authority to approve materials within assigned therapeutic area or product portfolio in accordance with internal standards.? Incumbent is responsible for assessing multiple competing tasks and demands, identifying priorities and managing deliverables.? Incumbent is responsible for prioritizing projects and seeking direction from supervisor as appropriate.? Incumbent is a contributor to the evaluation of vendor performance.? Incumbent is a contributor to identification of training needs for Global Medical Affairs personnel related to promotional activities and medical education programsThe role will have routine daily interactions with any of Shire?s internal functions; key functions include Global Medical Affairs, Regulatory Affairs, Business Units (Marketing, Sales, Commercial Operations) and Clinical Research and Development. External interactions include vendors providing services and project capabilities and professional organizations (eg, Drug Information Association, therapeutic-area specific organizations).The position is accountable to the Sr. Medical Affairs Director, Global Promotion and AdministrationDomestic and international travel may be required to support Medical Affairs activities. Duties may often call for early or late meeting and attendances at meetings on holidays and weekends.Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? Doctor of Pharmacy ( PharmD ) or Bachelor of Science degree in Pharmacy or equivalent.? Generally has 3 years pharmaceutical industry experience with 2-3 years experience in review of promotional material.? Experience in representing Medical Affairs functions in matrix teams.? In-depth understanding of global pharmaceutical regulations, guidelines, codes of practices and Shire policies related to promotional materials and activities and educational programs.? Demonstrated ability to accurately and effectively evaluate medical/scientific literature.? Excellent written and verbal communication skills? Demonstrated ability to learn/utilize computer applications? Good negotiation skills? Strong time management skills? Ability to work independently and as a member of cross-functional teams? Good analytical skills as applied to medical, scientific and technical informationApply to Shire