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Johnson & Johnson

Makes prescription drugs and medical devices

Manager, R&D - Clinical Research / Medical Affairs

Regulatory Compliance & EthicsPosted on Nov 6
Full-time$105k - $211k /yr

About the Job

Requirements

  • A bachelor's degree in Law, Business, Compliance, Finance, Healthcare Administration, Life Sciences, or a related field is required.
  • At least 5 years of experience in healthcare compliance, clinical research operations, medical affairs, legal, audit, or related functions is required.
  • Working knowledge of healthcare compliance laws, regulations, and industry standards applicable to clinical research and medical affairs is required.
  • Experience supporting risk-based compliance programs in regulated environments is required.
  • Ability to translate complex compliance requirements into practical guidance for business partners is required.
  • Strong analytical, problem-solving, and decision-making skills are required.
  • Effective written and verbal communication skills, with the ability to engage and influence stakeholders, are required.
  • Fluency in English is required.

Responsibilities

  • Provide strategic health care compliance leadership, oversight, and execution of the global health care compliance program for R&D, clinical research, medical affairs, and related activities, aligned with enterprise compliance frameworks and regulatory requirements.
  • Act as a compliance partner and trusted advisor to global R&D, clinical research, and medical affairs teams, providing timely, practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
  • Assist in identifying, assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
  • Support compliance risk assessments, issue management, and monitoring activities related to R&D, clinical research, and medical affairs.
  • Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
  • Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, clinical research, and medical affairs compliance.
  • Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.
  • Monitor regulatory, enforcement, and industry trends impacting R&D, clinical research, and medical affairs and escalate emerging risks as appropriate.
  • Drive continuous improvement by identifying opportunities to simplify processes and strengthen compliance effectiveness.

Desired Qualifications

  • An advanced degree or professional certification in Compliance, Legal, Risk, Ethics, or related disciplines is preferred.
  • Experience in medical devices, pharmaceuticals, or broader life sciences industries is preferred.
  • Familiarity with clinical trial conduct, investigator interactions, and scientific engagement models is preferred.
  • Experience working in matrixed organizations with cross-functional stakeholders is preferred.
  • Exposure to compliance risk assessments, monitoring, or issue management processes is preferred.
  • Change management or process improvement experience is preferred.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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