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SR Risk Management Specialist

SR Risk Management Specialist

J&J Family of CompaniesRaritan, NJ, US
16 hours ago
Job type
  • Full-time
Job description

Senior Risk Management Specialist

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Risk Management Specialist. This position will be located in Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The Sr. Risk Management Specialist will support Risk Evaluation and Mitigation Strategies (REMS) and general risk management activities for the Raritan, NJ Advance Therapies (AT) site.

Key Responsibilities :

  • Develop and support risk assessments for the Raritan manufacturing site.
  • Assist and lead development of and updates to SOPs and technical documents.
  • Assist in developing and maintaining robust metrics and measure for risk management program.
  • Support audits and inspections readiness and participate in site inspections and audits from internal and external regulatory agencies.
  • Assist in developing and maintaining robust risk management program and compliance documentation.
  • Other duties will be assigned, as needed.

Qualifications

Education :

  • Minimum of a Bachelor's or equivalent University degree is required.

    • Experience and Skills :

    Required :

  • Minimum four (4) years of experience in Risk management program, Regulatory Affairs, Pharmacovigilance, Medical Writing or similar.
  • Excellent interpersonal, influencing, written and verbal communication, listening, negotiating and problem-solving / decision-making skills.
  • Ability to work in an ambiguous environment.
  • Highly organized and capable of working with a cross-functional team.
  • Strong knowledge of risk management principles and tools.
  • Experience in applying ICH Q9 principles and risk-based approaches to the risk management program.
  • Practical knowledge of regulatory aspects of current Good Manufacturing Practice.
  • Strong critical thinking for evaluating risks across the site.

    • Preferred :

  • Knowledge of National and International manufacturing regulatory requirements (e.g., FDA / EU guidance).
  • Knowledge of Good Tissue Practices.
  • Familiarity with SAP, MES (electronic batch records), COMET (quality event management), or equivalent systems.

    • Other :

  • Occasional weekend and off shift support may be required.
  • Requires up to 10% domestic travel.
  • The anticipated salary for this position is expected to be between $77,000- $124,200 USD.

    • Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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    Risk Management Specialist • Raritan, NJ, US