Job Description Summary

Specialist, Senior Specialist, Medical Affairs is an integral member of Medical and Scientific Affairs (MSA) collaborating in cross functional teams. S/he represents MSA in core-team(s) involved with new product development and supporting medical sciences related with the BD products and deliverables in the different phases of product development. Activities may include authoring, editing, and reviewing documentation of design history files, clinical trial master file(s) supporting regulatory submission registrations and updates of the BD products. The Sr. Specialist has knowledge of BD reagents and flow cytometry instruments, software(s) and product development practices in commercial settings.

Job Description

We arethe 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 amakerof possiblewith us.

Job Summary:

As the Senior Specialist Medical Affairs at Becton, Dickinson and Company, you will play a pivotal role in our premier team. This is a remarkably outstanding opportunity to represent Medical and Scientific Affairs (MSA) in core teams during the different phases of new product development process. You will collaborate seamlessly across various departments such as Marketing, R&D, Design Assurance Engineering, Software Engineering, Systems Engineering, Regulatory Affairs, Quality Assurance, external vendors, and Key Opinion Leaders (KOL) to ensure detailed planning and execution of studies to establish the new product claims for regulatory submissions.

Key Responsibilities:

• Act as the face of MSA representative in the core teams dedicated to product development and pre-market studies of novel panel for flow cytometry applicable to detect specific markers relevant in acute myeloid leukemia.
• Collaborate with interdisciplinary teams to supply input throughout the planning and implementation of research projects.
• Demonstrate knowledge of Clinical Laboratory Standards Institute guidelines and Clinical American Pathologists guidelines.
• Understand IVDR and FDA regulations related to the use of human bio-specimens for testing, including privacy and safety for collection, IRB/IEC oversight, and country Health Authority requirements.
• Liaison and support clinical teams conducting external analytical studies and clinical trials. Experience with clinical study protocol writing, data analysis, and compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) is desirable.
• Share accomplishments in the MSA, like the Medical Affairs Department Plan, Investigator Brochure, support completion of the vital paperwork for different Regulatory Submissions, and noteworthy outcomes.
• Support MSA bio-specimen access efforts, including vendor/site identification and qualification, and collaborate with external investigators and KOLs.
• Carry out routine literature evaluations and merge intricate documents, such as the Investigator Brochure, performance reports for regulatory filings, or pre-submissions.
• Lead preparation, review and approval of diverse documents from inception through critical assessment and endorsement, aiding in Ethics review, Health Authority submissions, regulatory fillings, and evidence development.
• Familiarity and experience with BD Biosciences reagents and instruments.
• Participate in functional and cross-functional training to advance technical and regulatory knowledge and skills.
• Work under general supervision and report to MSA Management.

Minimum Requirement:

• Advanced Degree (PHD, PharmD or MD) or Master’s degree with equivalent and relevant experience.

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.

Click on Apply if this sounds like you!

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 visithttps://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 - Milpitas 135

Additional Locations

USA CA - San Diego (BDB)

Work Shift

NA (United States of America)

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

$92,700.00 - $152,900.00 USD Annual