Senior Specialist, Specimen Management Medical Affairs / Scientific Affairs
BDAbout the role
Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
BD Specimen Management (SM) is seeking a Senior Specialist, Scientific Affairs (SSSA) in the Specimen Management business unit of Life Sciences. The SSSA has basic understanding of unmet medical/clinical lab needs. The SSSA applies experience in clinical chemistry lab and knowledge of clinical trial design and study conduct when interacting with project and platform teams. Provides input to the Medical Affairs Strategy Document, the Clinical Trial Plan and the Evidence Generation Plan. They may generate clinical trial protocols and clinical reports for BD studies, and they are also responsible for reviewing Investigator Sponsored Studies (ISS) proposals. Responsibilities may also include developing or contributing to clinical evidence plans in their focus area including publication strategies. The SSSA will lead or contribute to journal publications and scientific conference presentations and represent Medical/Scientific Affairs in market development activities. The SSSA will maintain relationships with Key Opinion Leaders and have an understanding of product utility and links to potential patient outcomes. The SSSA will act in the capacity of an instrument company liaison role with alliance companies that develop instruments and assays that utilize BD SM products. Aspects of the role include Global and USA medical science liaison activities.
Franklin Lakes, New Jersey (Hybrid)
Key responsibilities will include:
- Applies technical expertise in hematology, coagulation, blood bank, clinical chemistry, or immunochemistry.
- Knowledge of other related fields such as design control and product development, statistics and data management is preferred. Interprets and describes low to moderate complexity data.
- Responsibilities include designing and handling post market studies, ISS and research collaborations in the area of hematology, coagulation, blood bank, clinical chemistry, automated chemistry (general, high-volume testing), special chemistry (electrophoresis, immunoassay, chromatography, etc.), toxicology and therapeutic drug monitoring, critical care (blood gases and specific stat testing), and pediatric metabolism (organic acids, amino acids).
- The SSSA will have visibility to all global and regional studies within their focus area.
- Develops instrument company compatibility plan and liaises with clinical hematology & chemistry instrument companies to update BD specimen containers compatibility across these instruments.
- Applies technical expertise, guidelines, and product knowledge to support post-market customer inquiries including scientific exchange and off-label inquiries.
- Performs medical review of advertising and promotional materials.
- Works independently with minimum supervision. Interacts with senior manager as required for specific issues, achievements, or status changes. Must have excellent communication skills – in person as well as virtual.
- Ability to work in a highly matrixed organization.
- Independently develops training material requiring review by others. Reviews training materials prepared by others. Excellent writing and presentation skills.
- Builds and delivers presentations to all audiences, including Senior Management and partners.
Education and experience required:
- Bachelor’s degree is required in laboratory sciences or related field.
- Experience with IVD clinical trials in particular venipuncture, capillary blood sampling, clinical hematology, chemistry and human factor studies
- 1-2 years’ experience in specimen collection and management and with clinical hematology or chemistry or blood bank such as: automated chemistry (general, high-volume testing), special chemistry (electrophoresis, immunoassay, chromatography, etc), toxicology and therapeutic drug monitoring, critical care (blood gases and specific stat testing)
Travel:
- Travel in USA and international, up to 10%.
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