Medical Affairs Manager IPD

Becton Dickinson Medical Devices•San Diego, CA

8d•Onsite

About The Position

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. 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. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Requirements

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%)

Nice To Haves

At least 2 years of experience in the medical device or pharmaceutical industry (clinical research or medical affairs)
Experience in medical affairs operations with knowledge of regulatory obligations
Experience with Clinical Trials
Experience developing clinical strategies that lead to efficient product development
Familiarity with safety reporting requirements for both pharmaceuticals and medical devices
Experience presenting to both small groups and large audiences
Demonstrated business acumen and industry knowledge

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.