Senior Manager, Medical Affairs, MMS Infusion

Becton Dickinson Medical Devices•San Diego, CA

27d•Onsite

About The Position

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.

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

Nice To Haves

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

Responsibilities

Support the risk management process for the BD Infusion product line, focusing on the Alaris System with Guardrails and related applications.
Maintain projects and develop improvements for in-market solutions.
Offer clinical expertise and input during the creation of deliverables based on field issues, industry standards, and established protocols.
Update Risk-Benefit Analyses and take part in all final reviews.
Assist cross-functional teams with FDA 510(k) submissions, audits, and other tasks related to Regulatory compliance and Quality Assurance, as assigned by management.
Write or contribute to Clinical Evaluation Reports (CERs) and Risk-Benefit Analyses (RBAs) as needed.
Develop valid clinical test protocols and relevant workflows and structures.
Support internal and external customer activities related to safety and performance, such as conference calls, training, written correspondence, and medical reviews of marketing collateral.
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.
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.
Present medical and scientific information to both internal and external audiences.
Give feedback and insights to Medical/Clinical Teams based on your interactions with healthcare professionals.
Support post-market surveillance activities, such as off-label inquiries and risk assessments.

Benefits

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume