Job Description Summary

This position has the responsibility to provide medical and scientific input in support of the Infusion Preparation and Delivery Business Group initiatives.

This role provides medical and clinical input as it pertains to new product development activities, marketing initiatives, quality assurance and regulatory product requirement support.

Clinical input is expected towards the maximization of current and future products within the assigned platforms.

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. 

Medical Affairs Manager, Infusion Preparation & Delivery (IPD)

Scope:

In this role under the Director of Medical Affairs IPD, the focus is on providing medical and scientific expertise for the Infusion Preparation and Delivery Business Group. Responsibilities include supplying clinical insights for new product development, marketing strategies, quality assurance, and regulatory support.

What makes this opportunity outstanding? At BD, you will have the chance to work with a world-class team dedicated to advancing healthcare solutions with outstanding precision. By joining us, you will play a pivotal role in crafting the future of medical technology and making a tangible impact on global health.

Responsibilities:

• Present the medical affairs role within the core team, aiding product development, remediation projects, and meeting medical device regulatory needs.

• Review, comprehend, and compose performance and safety reporting requirements for medical devices to align with global regulations.

• Support regulatory submissions towards EU MDR requirements, including but not limited to, the review of product labels, intended use, intended population, use environment, warnings, and precautions.

• Contribute to the development and implementation of research and projects in areas of interest globally; support in the development of plans for studies.

• Manage the dissemination of scientific and medical information to both internal and external clients in accordance with legal and regulatory standards.

• Review promotional and educational material for accuracy; support consultant and advisory meetings; and coordinate grant applications for scientific merit.

• Develop risk management documents and ensure that all product failure modes and risk mitigation measures are included.

• Contribute when necessary to the crisis-management teams for promoted products, such as during field corrective actions.

• Develop responses to inquiries on BD products.

• Regularly review scientific literature in collaboration with marketing for key products.

• Continuously develop knowledge of regulatory, pharmacovigilance, and quality assurance requirements in alignment with BD Practice Standards.

Required Qualifications

• Minimum 5 years of experience in clinical practice

• Knowledge of Good Clinical Practice (GCP)

• Ability to identify unmet clinical needs and evaluate product opportunities from a clinical perspective

• Strong critical thinking skills with ability to articulate complex issues both orally and in writing

• Goal-oriented with focus on achieving outcomes and completing tasks promptly

• Excellent prioritization skills and adaptability in a dynamic environment

• Outstanding written and verbal communication skills

• Proficiency with computer software applications

• Strong presentation skills for delivering scientific and medical data to various audience sizes

• Willingness and ability to travel domestically or internationally (approximately 20%)

Preferred Qualifications

• At least 2 years of experience in the medical device or pharmaceutical indus