Job Description SummaryJob DescriptionReporting to the WW Director, Medical Affairs (MA), this position has the responsibility to provide medical, scientific, technical and customer-focused support.Provides guidance from a medical perspective to value maximization of current and future products and processes for the respective platforms.Participates in innovation, technology development and product development core teams by sensing and defining key trends and unmet needs in science, technology, medical practice, and health economics. Participates in sustaining engineering teams by reviewing information and assessing risks related to material and manufacturing process changes. Provides customer and product knowledge to team. Identifies appropriate clinical and/or other defined testing to address clinical risks for product changes. Develops safety and efficacy requirements and a clinical test plan to address S&E, Regulatory and Marketing requirements for new and improved products and gains functional approval of such. With the support of the MA team, ensures safety, efficacy and clinical utility of the product, technology and related labelling/promotional material. Reviews and interprets medical/scientific data and study results, and technical literature. Monitors trends in Anesthesia and medication management. Communicates findings and interpretations to teams and management.Interacts with global medical, academic and industry experts to establish strategic direction for innovation, technology and product development projects.Provides clinical support to products entering or currently on the market including training of customers and BD associates, troubleshooting, data review, interpretation and presentation, post market study design, publications, preparation or review of regulatory communications, and addressing quality issues.Designs studies, formulates and conducts scientific investigations, feasibility studies, and due diligence studies related to new technologies and products. Interprets and presents results. Prepares technical reports, abstracts, journal submissions and present at scientific meetings or within BD.Perform risk management to minimize product risk from clinical use perspective.Provides clinical consultation for HEOR studies, post market surveillance and post market studies. Contribute to the development and implementation of clinical research and educational projects in areas of interest globally; participate in the development of plans for future clinical studies.Guide design of clinical trials and registries globally. Ensure support for activities in clinical development by collaborating with the clinical operations group.Direct the distribution of scientific and medical information to internal and external customers while meeting appropriate legal and regulatory guidelines.Co-develop appropriate strategic go-to-market models with business group and commercial teams.Direct the identification and development of KOLs across different therapy areas as needed, investigate new uses of BDs products, and ensure collaboration with appropriate scientific societies. Be part of an environment that stresses open, candid, and timely feedback relative to performance.Continuously develop knowledge of regulatory, pharmacovigilance and quality assurance requirements in alignment with BD Practice Standards.Qualifications:CRNA (Certified Registered Nurse Anesthetist) or MD Anesthesiologist.3-5 Years in Medical Practice.Experience in the medical device or pharmaceutical industry within clinical research or preferably medical affairs as a plus.Clinical trial experience with solid knowledge of Good Clinical Practice (GCP).Demonstrate strong business acumen and critical thinking skills.Process-oriented and demonstrates a sense of urgency in completing deliverables through effective goal setting and a strong result orientation.Must be able to organize, prioritize and work effectively in a constantly changing environment.Excellent written, oral communication and computer software skills. Excellent presentation skills of scientific and medical data to small and large audiences.Knowledgeable in the areas of regulatory, commercial and clinical issues affecting the pharmaceutical /medical device industry. Demonstrate ability to identify unmet clinical needs, evaluate product opportunities from a clinical perspective, and help develop strategies that leads to efficient development of such opportunities.Working knowledge of safety reporting requirements for both drugs and devices.Ability and willingness to travel 10-20% of time.LI-TECHPrimary Work LocationUSA NJ - Franklin LakesAdditional LocationsWork ShiftFull time Associated topics: affair, drug safety, health economic and clinical outcomes research, health economic and outcomes research, hecor, heor, liaison, medical affairs, protocol, usage
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