Job Description Summary

BD Diagnostic Solutions (DS) is seeking an experienced Principal in our Medical Affairs department located in Sparks, MD. This role is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area. Responsibilities include representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives and participating in critical product development decisions. The Principal demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs, Quality, Business, or Project Management). The Principal is recognized as the MA technical subject matter expert across units or functions (for example, product development teams, business/unit or MA leadership teams).

The Principal represents the interest of the patient and the health care worker and has advanced understanding of unmet medical/clinical needs and provides input into product design on behalf of MA and contributes to ongoing evaluations of product safety. The Principal applies expert knowledge of clinical trial design and conduct of highly complex studies when interacting with the extended clinical operations team and is responsible for writing the Medical Affairs Strategy Document as well as the Clinical Trial Plan. The Principal has expert knowledge of local regulations and BD policies and procedures and advanced knowledge of BD products, product development process, ISO standards and elements of design control. The Principal will contribute to regulatory strategies and interactions with US and ex-US regulatory authorities and/or Standards Committees.

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. 

BD Diagnostic Solutions (DS) is seeking an experienced Principal in our Medical Affairs department located in Sparks, MD. This role is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area.  Responsibilities include representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives and participating in critical product development decisions.  The Principal demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs, Quality, Business, or Project Management). The Principal is recognized as the MA technical subject matter authority across units or functions (for example, product development teams, business/unit or MA leadership teams).

The Principal represents the interest of the patient and the health care worker and has advanced understanding of unmet medical/clinical needs and provides input into product design on behalf of MA and contributes to ongoing evaluations of product safety. The Principal applies authoritative knowledge of clinical trial design and conduct of highly complex studies when interacting with the extended clinical operations team and is responsible for writing the Medical Affairs Strategy Document as well as the Clinical Trial Plan. The Principal has authoritative knowledge of local regulations and BD policies and procedures and advanced knowledge of BD products, product development process, ISO standards and elements of design control. The Principal will contribute to regulatory strategies and interactions with US and ex-US regulatory authorities and/or Standards Committees.

Responsibilities also include developing clinical evidence plans to include publication strategies.  The Principal will help coordinate and lead the team through journal publications and scientific conference presentations and represent Medical Affairs in market development activities.  The Principal will maintain relationships with Key Opinion Leaders and have an advanced understanding of product utility and links to potential patient outcomes.

Additional responsibilities may also include building operational functional excellence in product development and cl