BD (Tissuemed Ltd)
Medical Affairs Manager IPD
Join BD (Tissuemed Ltd), a global medical technology company dedicated to advancing health. This role provides medical and scientific expertise for the Infusion Preparation and Delivery Business Group.
Job Description Summary Support Infusion Preparation & Delivery initiatives by providing medical and scientific input, clinical insights for new product development, marketing strategies, quality assurance, and regulatory product requirement support.
Responsibilities
Present the medical affairs role within the core team, aiding product development, remediation projects, and meeting medical device regulatory needs.
Review, comprehend, and compose performance and safety reporting requirements for medical devices to align with global regulations.
Support regulatory submissions towards EU MDR requirements, including product labels, intended use, intended population, use environment, warnings, and precautions.
Contribute to the development and implementation of research and projects globally, support planning of studies.
Manage the dissemination of scientific and medical information to internal and external clients in accordance with legal and regulatory standards.
Review promotional and educational material for accuracy; support consultant and advisory meetings; coordinate grant applications for scientific merit.
Develop risk management documents and ensure all product failure modes and risk mitigation measures are included.
Contribute when necessary to crisis‑management teams for promoted products during field corrective actions.
Develop responses to inquiries on BD products.
Review scientific literature in collaboration with marketing for key products.
Continuously develop knowledge of regulatory, pharmacovigilance, and quality assurance requirements in alignment with BD Practice Standards.
Required Qualifications
Minimum 5 years of experience in clinical practice.
Knowledge of Good Clinical Practice (GCP).
Ability to identify unmet clinical needs and evaluate product opportunities from a clinical perspective.
Strong critical thinking and ability to articulate complex issues orally and in writing.
Goal‑oriented with focus on achieving outcomes and completing tasks promptly.
Excellent prioritization skills and adaptability in a dynamic environment.
Outstanding written and verbal communication skills.
Proficiency with computer software applications.
Strong presentation skills for delivering scientific and medical data to various audience sizes.
Willingness and ability to travel domestically or internationally (≈20%).
Preferred Qualifications
At least 2 years of experience in the medical device or pharmaceutical industry (clinical research or medical affairs).
Experience in medical affairs operations with knowledge of regulatory obligations.
Experience with Clinical Trials.
Experience developing clinical strategies that lead to efficient product development.
Familiarity with safety reporting requirements for both pharmaceuticals and medical devices.
Experience presenting to both small and large audiences.
Demonstrated business acumen and industry knowledge.
Primary Work Location USA, NJ – Franklin Lakes.
Salary Range Information $130,400.00 – $215,200.00 USD Annual.
Benefits Work in a culture of collaboration, flexibility, and innovation. In most roles a minimum of 4 days per week in‑office is required, with remote or field‑based arrangements indicated in the posting. Employees must be fully vaccinated against COVID‑19.
Our Commitment We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility, veteran status, and other legally protected characteristics.
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Job Description Summary Support Infusion Preparation & Delivery initiatives by providing medical and scientific input, clinical insights for new product development, marketing strategies, quality assurance, and regulatory product requirement support.
Responsibilities
Present the medical affairs role within the core team, aiding product development, remediation projects, and meeting medical device regulatory needs.
Review, comprehend, and compose performance and safety reporting requirements for medical devices to align with global regulations.
Support regulatory submissions towards EU MDR requirements, including product labels, intended use, intended population, use environment, warnings, and precautions.
Contribute to the development and implementation of research and projects globally, support planning of studies.
Manage the dissemination of scientific and medical information to internal and external clients in accordance with legal and regulatory standards.
Review promotional and educational material for accuracy; support consultant and advisory meetings; coordinate grant applications for scientific merit.
Develop risk management documents and ensure all product failure modes and risk mitigation measures are included.
Contribute when necessary to crisis‑management teams for promoted products during field corrective actions.
Develop responses to inquiries on BD products.
Review scientific literature in collaboration with marketing for key products.
Continuously develop knowledge of regulatory, pharmacovigilance, and quality assurance requirements in alignment with BD Practice Standards.
Required Qualifications
Minimum 5 years of experience in clinical practice.
Knowledge of Good Clinical Practice (GCP).
Ability to identify unmet clinical needs and evaluate product opportunities from a clinical perspective.
Strong critical thinking and ability to articulate complex issues orally and in writing.
Goal‑oriented with focus on achieving outcomes and completing tasks promptly.
Excellent prioritization skills and adaptability in a dynamic environment.
Outstanding written and verbal communication skills.
Proficiency with computer software applications.
Strong presentation skills for delivering scientific and medical data to various audience sizes.
Willingness and ability to travel domestically or internationally (≈20%).
Preferred Qualifications
At least 2 years of experience in the medical device or pharmaceutical industry (clinical research or medical affairs).
Experience in medical affairs operations with knowledge of regulatory obligations.
Experience with Clinical Trials.
Experience developing clinical strategies that lead to efficient product development.
Familiarity with safety reporting requirements for both pharmaceuticals and medical devices.
Experience presenting to both small and large audiences.
Demonstrated business acumen and industry knowledge.
Primary Work Location USA, NJ – Franklin Lakes.
Salary Range Information $130,400.00 – $215,200.00 USD Annual.
Benefits Work in a culture of collaboration, flexibility, and innovation. In most roles a minimum of 4 days per week in‑office is required, with remote or field‑based arrangements indicated in the posting. Employees must be fully vaccinated against COVID‑19.
Our Commitment We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility, veteran status, and other legally protected characteristics.
#J-18808-Ljbffr