Job Description Summary

The Senior Manager, Medical Affairs MMS Infusion is primarily responsible as the “voice of the end user” to help ensure the BD infusion products released to market are safe and effective. Medical Affairs (MA) plays a significant role in new product development to include Key Opinion Leader engagement on innovate technologies, identification of user needs and requirements, participation of Human Factors validation testing and assessments of hazards, all to ensure product safety and performance for our patients and end users. MA also plays a large role in Post Market Surveillance by assessing risks and hazards, Risk-Benefit determinations, the development of post market risk estimation criteria, Clinical Evaluation Reports, and support of internal / external audits.

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. 

As the Medical Affairs clinical pharmacist delegate, you will support the risk management process for the BD Infusion product line, focusing on the Alaris System with Guardrails and related applications. Your efforts will help maintain projects and develop improvements for in-market solutions. This includes offering clinical expertise and input during the creation of deliverables based on field issues, industry standards, and established protocols. You will also update Risk-Benefit Analyses and take part in all final reviews.

You will assist cross-functional teams with FDA 510(k) submissions, audits, and other tasks related to Regulatory compliance and Quality Assurance, as assigned by management. You will also write or contribute to Clinical Evaluation Reports (CERs) and Risk-Benefit Analyses (RBAs) as needed.

In your role as a Subject Matter Expert (SME), you will develop valid clinical test protocols and relevant workflows and structures. You will also support internal and external customer activities related to safety and performance, such as conference calls, training, written correspondence, and medical reviews of marketing collateral.

You will be a core team member on enhancement development projects for in-market solutions and support evidence generation activities in cooperation with functional partners like HEOR and Marketing. You will exchange complex medical and scientific unbiased information with the healthcare community and develop significant scientific relationships with Key Opinion Leaders (KOLs) and other disease experts.

You will present medical and scientific information to both internal and external audiences. You will also give feedback and insights to Medical/Clinical Teams based on your interactions with healthcare professionals. Supporting post-market surveillance activities, such as off-label inquiries and risk assessments, will be part of your role.

Minimum Requirements:

• Pharmacy degree
• At least 5 years of clinical practice experience
• At least 5 years of experience managing smart pump drug libraries and datasets
• Experience with infusion devices, infusion analytics, informatics, and smart pump interoperability; prior clinical practice and experience with BD Alaris specifically
• Experience in sustained development efforts and managing projects
• Experience in and/or managing studies including literature reviews, study development and execution, and compliance monitoring
• Strong verbal and written communication abilities
• Ability to exercise independent judgment and discretion
• Demonstrated ability to balance multiple tasks and prioritize work
• Demonstrated organizational, planning, and project management skills
• Ability to be effective in complex projects with ambiguity and/or rapid change
• Orientation for detailed work, with emphasis on accuracy and completeness

Preferred Qualifications:

• PharmD (Doctor of Pharmacy)
• 10 years of clinical practice experience
• Experience in the medical device industry or medical affairs; experience in risk management, post-market surveillance, cybersecurity, field action decisions, and business development
• Previous experience with crafting medical strategy, developing teams, and implementing medical processes; prior management experience
• Experience in medical writing, publishing, and presenting at professional conferences

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.  

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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$158,300.00 - $261,100.00 USD Annual