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Senior Associate Director, Medical Information
3 months ago
DescriptionThe Sr. AD Scientific Affairs Medical Information and Medical Review is responsible for developing, maintaining and continuously improving Medical Information (MI) assets and for review and approval of medical and promotional materials as part of the Human Pharma Review Committee (HPRC) review team. This individual will work closely with the Medical Affairs Strategy teams and Global Medical Information (MI) to ensure the timely development of scientific content for internal and external utilization based on customer needs and aligned with global MI content. This individual is also responsible for medical review of materials utilized by commercial and medical colleagues ensuring data is medical and scientifically accurate, not misleading, supported with appropriate context and is consistent with current medical perspective. Collaborating with all HP functions is expected in order to ensure timely support of any medical or commercial initiatives.Strong expertise and knowledge of medical information will ensure for accurate and regionally appropriate preparation of scientific content, U.S. MI requests, process, system and therapeutic area (TA) knowledge management, as well as support of compliance needs, and training for internal business functions and functional area vendors. The incumbent ensures a strategic, value added MI organization by collaborating with a team that is well aligned with business priorities, Medicine strategy, customer initiatives, and maintaining a feedback mechanism with customers to improve Boehringer Ingelheim's MI assets and distribution.The individual is also expected to be familiar with Brand and Medical strategies, FDA guidelines for advertising and promotional review, and current therapeutic area landscape in order to ensure appropriate and accurate execution of medical review as part of a cross collaborative review committee.The incumbent also provides subject matter expertise in medical information for continuously understanding customer needs and delivering medical information to reflect those needs (format, delivery method and content), planning, execution, and improvement of process as well as to help with on-boarding, training and guidance of Clinical Development and Medical Affairs (CDMA) TA team members.Duties & ResponsibilitiesWorks with TA to provide strategic insights on customer MI needs in real-time and as part of local Medical Affairs Planning and in response to evolving external environment demands for the development of Medical strategies.Seeks input from key local and global HP stakeholders to ensure alignment of strategies with customer needs.Responds to medical inquiries from healthcare professionals and patients via phone, email, or other channels.Researches and provides accurate and evidence-based medical information on company's products.Supports development and review of medical information materials.Collaborates with cross-functional teams to ensure consistent and accurate communication of medical information.Maintains accurate documentation of review activities and provides feedback to stakeholders.Provides medical training and support to internal stakeholders.Reviews and provides medical and scientific expertise to ensure accuracy and compliance of promotional and non-promotional materials.Verifies scientific accuracy, data integrity, and clinical relevance of content.Collaborates with cross-functional teams to provide medical input throughout the review process.Maintains comprehensive understanding of product information, clinical data, regulatory guidelines, and industry best practices.Provides mentorship and guidance to new Medical Information team members.Facilitates onboarding process for new hires in the Medical Information team.Performs all Company business in accordance with regulations and Company policies.Demonstrates high ethical and professional standards with customers.Works with Medical Affairs Strategy and/or the Scientific Affairs Medical Information & Medical Review Team Lead to develop training programs and enhance internal awareness of MI group.Collaborates with Medicine Excellence Customer Facing colleagues to support vendor training.Provides support for department core functions as needed.May participate in external activities relevant to MI to enhance individual and Boehringer Ingelheim reputation for MI excellence.RequirementsAdvanced Degree Related to Healthcare focus(e.g. PharmD, NP/PA, MD, PhD) from an accredited institution.Minimum of 2 years of experience in a clinical practice environment (including Residency training)as well 3+ years of industry experience, preferably with experience in development and/ or medical affairs.AD: At least three to five (3-5) years pharmaceutical industry experience or completion of a two year Boehringer Fellowship program (in MI or equivalent as defined by medical information expertise).Sr. AD: At least seven (7) years pharmaceutical industry experience (in MI or equivalent as defined by medical information expertise).Possess clinical knowledge of the assigned TA(s), understanding of the clinical development process, medical affairs functions, product commercialization, and pharmaceutical regulations and regulatory requirements.International experience may be relevant but knowledge and experience with US MI practice is essential. Must have experience in provide leadership and supervision of staff across medical information and third-party vendors and ensure compliance with existing SOPs, policies and work instructionsDemonstrated customer focus and customer satisfaction as well as demonstrated continuous improvement of processes/assetsDemonstrated ability to work cross-functionally at the franchise level and at all levels across the enterprise. Exhibits flexibility in working collaboratively across internal and external stakeholders.Highly developed abilities in influence and working effectively through others. Demonstrated business acumen and judgment with ability to balance need for maintaining high scientific standards with business relevance and impact. Possess excellent communication skills.CompensationThis position offers a base salary typically between $135,000 and $232,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. 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