JOB DESCRIPTION SUMMARY

The Manager, Medical Affairs MMS Infusion is primarily responsible as the “voice of the end user” to help ensure that BD infusion products released to the market are safe and effective. Medical Affairs (MA) plays a significant role in new product development to include Key Opinion Leder (KOL) engagement on innovative technologies, identification of user needs and requirements, participation in human factors validation testing and assessment of hazards, all to ensure product safety and performance for our end users and patients

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.

EDUCATION AND EXPERIENCE:

• RN
• Minimum Bachelor Nursing (BSN) required.
• Minimum 5 years clinical nursing practice experience required, 10 years preferred.
• Experience in medical writing and presenting.
• Preferred: Recent cardiac critical care (CCU) or intensive care unit (ICU) experience
• Preferred: Experience in the medical device industry or medical affairs
• Preferred: Experience with infusion devices, informatics, and connected medical technology

• Core team member on new product development projects focused on critical care centric solutions including infusion of medications/fluids and patient monitoring (e.g., vital signs and hemodynamics), and the connectivity of these devices to support clinical outcomes.
• Provides medical/clinical input to new product development, marketing initiatives, quality assurance, regulatory product support, medical management and documentation of quality, risk, evidence, KOL engagement and customer focused support.
• As the Medical Affairs clinical delegate, supports the risk management process for the BD infusion product line (pre-market and post-market) with emphasis on connectivity with patient monitoring. This includes providing guidance and input during the creation of risk management deliverables based on field issues, industry standards and best practices; development of updates of Risk-Benefit Analysis and participation in collaboration.
• Authors and provides input into Risk Benefit Analysis (RBAs) as required or directed by management.
• Serve as the subject matter expert (SME) for developing valid clinical test protocols which may involve creation of clinically relevant designs and/or workflows. Understand the implications of any new required workflow.
• Participates in cross-functional team support for FDA submissions, internal or external audits, or other such activities for regulatory compliance and quality assurance efforts as directed by management.
• Support evidence generation activities as directed by manager in cooperation with functional partners such as marketing and HEOR (Health Economics and Outcomes Research).
• As the clinical subject matter expert, support internal / external customer activities related to safety and performance.
• Support the infusion business in the development, review, and approval of new marketing/sales materials (Veeva Vault).
• Assist the infusion business in reviewing/updating IFUs (instructions for use).
• Provide medical/scientific presentations to internal and external groups.
• Develop significant scientific relationships with Key Opinion Leaders (KOLs) and other clinical experts.