Medical Affairs, Senior Manager

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.

• →Provides leadership and assistance to the EP ASCP and ASVP staff and allied associates on matters pertaining to the Programs’ services, policies, procedures, and staff, as directed by the VP, EP
• →Hires, evaluates and manages EP associates, contractors and/or vendor personnel who engage in Program activities, as assigned.
• →Works alongside the Director, EP to help support global or regional locations or Business Units who wish to expand Program activities in existing or new locations.
• →Responsible for all submissions and communications with the ASCP IRB and EC
• →Responsible for providing monitoring expertise to the project team and effectively manage assigned clnical site(s)/project(s)
• →Oversee and ensure site staff execute protocols according to plan (protocol) and in compliance with regulatory requirements/standards (GCP/ISO), IRB/EC policies and procedures, and BD established standards
• →Prioritize subject safety is maintained and informed consent procedures are carried out and documented properly
• →Maintain complete and audit-ready regulatory files for assigned site(s)/project(s) that comply with company and industry parameters, e.g. ALCOA
• →Required to be onsite daily in Franklin Lakes, NJ.

• Licensed Healthcare Practitioner (HCP), such as RN, PA, NP. Minimum Bachelor’s degree in a Science related field
• Certifications in clinical trial management from recognized training entities (is a plus)
• Minimum 5 years’ experience in human clinical trials (GCP experience preferred)
• Minimum 5 years’ experience in Program Management activities and in people management
• Minimum 3 years’ experience in Site Monitoring (preferred)

• Excellent communication and presentation skills, proficiency in interacting productively with internal and external customers
• Ability to anticipate and resolve problems
• Ability to lead cross-functional efforts and teams
• Ability to work independently as well as collaboratively within a team setting
• Ability to write clearly and analytically; fluent in English

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.

Health and Well-being Benefits  

• Medical coverage  

• Health Savings Accounts  

• Flexible Spending Accounts  

• Dental coverage  

• Vision coverage  

• Hospital Care Insurance  

• Critical Illness Insurance  

• Accidental Injury Insurance  

• Life and AD&D insurance  

• Short-term disability coverage  

• Long-term disability insurance  

• Long-term care with life insurance  

Other Well-being Resources  

• Anxiety management program  

• Wellness incentives  

• Sleep improvement program  

• Diabetes management program  

• Virtual physical therapy  

• Emotional/mental health support programs  

• Weight management programs  

• Gastrointestinal health program  

• Substance use management program  

• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit  

Retirement and Financial Well-being  

• BD 401(k) Plan  

• BD Deferred Compensation and Restoration Plan  

• 529 College Savings Plan  

• Financial counseling  

• Baxter Credit Union (BCU)  

• Daily Pay  

• College financial aid and application guidance  

Life Balance Programs  

• Paid time off (PTO), including all required State leaves  

• Educational assistance/tuition reimbursement  

• MetLife Legal Plan  

• Group auto and home insurance  

• Pet insurance  

• Commuter benefits  

• Discounts on products and services  

• Academic Achievement Scholarship  

• Service Recognition Awards  

• Employer matching donation  

• Workplace accommodations  

Other Life Balance Programs  

• Adoption assistance  

• Backup day care and eldercare  

• Support for neurodivergent adults, children, and caregivers  

• Caregiving assistance for elderly and special needs individuals  

• Employee Assistance Program (EAP)  

• Paid Parental Leave  

• Support for fertility, birthing, postpartum, and age-related hormonal changes  

Leave Programs  

• Bereavement leaves  

• Military leave  

• Personal leave  

• Family and Medical Leave (FML)  

• Jury and Witness Duty Leave