BD

Medical Affairs Manager

BD

full-time

Posted on:

Location Type: Hybrid

Location: Franklin Lakes • New Jersey • Utah • United States

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Tech Stack

Google Cloud Platform

About the role

  • Serve as the strategic medical voice within cross‑functional teams, shaping product development, lifecycle management, remediation initiatives, and global regulatory strategy to ensure clinical relevance and patient safety.
  • Interpret, develop, and maintain clinical performance and safety reporting requirements in alignment with evolving global regulations, including EU MDR, and other regional standards.
  • Support regulatory submissions and technical documentation, including but not limited to, providing medical review of labeling, intended use statements, target populations, clinical claims, risk‑benefit narratives, and safety‑related content.
  • Support and/or contribute to global clinical evidence generation activities, including protocol development, study design input, real‑world evidence initiatives, and post‑market clinical follow‑up (PMCF) planning.
  • Oversee the compliant dissemination of scientific, clinical, and medical information to internal stakeholders, healthcare professionals, and external partners, ensuring alignment with regulatory and industry standards.
  • Review and approve promotional, educational, and training materials for scientific accuracy and compliance; support advisory boards, expert panels, and scientific engagement activities; and coordinate independent research or educational grant requests.
  • Develop, maintain, and review risk management documentation, ensuring comprehensive identification of failure modes, clinical risks, and mitigation strategies throughout the product lifecycle.
  • Participate in crisis‑management and field action teams, providing medical expertise during product quality events, safety investigations, and corrective or preventive actions.
  • Respond to medical inquiries and provide scientifically sound, evidence‑based information regarding the company’s products, indications, and clinical data.
  • Monitor and synthesize emerging scientific literature, clinical trends, and competitive intelligence, collaborating with marketing and R&D to inform strategy and messaging.
  • Stay current with global regulatory, clinical, pharmacovigilance, and quality requirements, ensuring alignment with internal standards and supporting continuous organizational readiness.

Requirements

  • RN, PharmD, or equivalent clinical education.
  • Minimum of 5 years of clinical practice experience with strong patient‑care insight.
  • At least 2 years of relevant experience in the medical device or pharmaceutical industry, ideally within clinical research or medical affairs.
  • Demonstrated experience in medical affairs operations, including support for regulatory and compliance obligations.
  • Working knowledge of clinical trial processes and Good Clinical Practice (GCP) standards.
  • Proven ability to identify unmet clinical needs, assess product opportunities from a clinical and scientific perspective, and contribute to evidence‑based development strategies.
  • Strong business acumen and critical‑thinking skills, with the ability to clearly communicate complex scientific and strategic concepts in both written and verbal formats.
  • Highly organized and results‑oriented, with a track record of setting clear goals and driving timely execution.
  • Ability to prioritize effectively and thrive in a dynamic, fast‑changing environment.
  • Exceptional communication and presentation skills, including the ability to deliver scientific and medical content to diverse audiences; proficient with standard business and scientific software tools.
  • Familiarity with safety reporting requirements for both medical devices and pharmaceuticals.
  • Willingness and ability to travel domestically and internationally up to 20%.
Benefits
  • Annual Bonus Potential
  • Discretionary LTI Bonus Potential
  • reimbursement of phone use
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical performance reportingsafety reporting requirementsregulatory submissionsprotocol developmentstudy designrisk management documentationclinical trial processesGood Clinical Practice (GCP)evidence-based development strategiespharmacovigilance
Soft Skills
critical-thinkingcommunication skillsorganizational skillsresults-orientedability to prioritizebusiness acumenability to thrive in dynamic environmentspresentation skillscollaborationstrategic thinking
Certifications
RNPharmDclinical education equivalent