Sr. Manager Medical Affairs

Manager, Medical Affairs MMS Infusion

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 Leader (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.

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

Job Responsibilities :

• 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.

Education and Experience :

Position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities.

Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

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.

Why Join Us?

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.

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.

Salary Range Information $158,300.00 - $261,100.00 USD Annual