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Risk Management Associate

Job Description

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. Learn more at and follow us @JanssenGlobal. Actelion Pharmaceuticals US Inc is part of the Janssen Pharmaceutical Companies.

Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson is recruiting for a Risk Management Associate, located in South San Francisco, CA. Remote candidate will also be given consideration if able to travel to up to 10%.

Job Description:

Under the oversight of the U.S. Risk Management Project Lead, handle execution and development, implementation, monitoring, and assessment of Risk Evaluation and Mitigation Strategies (REMS) and general U.S. risk management strategy.

Key Responsibilities:

  • Support REMS Assessment Report project planning, data collection, development, review, and approval
  • Oversee response development for FDA information requests
  • Propose and/or assist in the development of REMS modifications
  • Lead or support REMS modification implementation
  • Lead vendor in development, revision, and execution of survey studies to measure the effectiveness of the REMS programs
  • Support REMS Core Team meetings
  • Develop strong working relationship with REMS Core Team members
  • Provide REMS Steering Committee with status reports, proposals, and materials for review and approval
  • Train internal and external partners about the REMS programs
  • Assist in developing and updating REMS SOPs as appropriate
  • Contribute to electronic review, approval, and archiving software, including development of new REMS specific workflows
  • Develop and maintain robust files for all REMS related documents
  • Manage audit CAPAs when necessary


Specialist Experience


  • Bachelor’s Degree required, life sciences discipline preferred 

Experience and Skills:

  • A BS/BA degree and 5 years of related experience OR equivalent combination of an advanced degree (masters, MBA, etc.) and related experience equaling at least 5 years required 
  • At least 1 year of experience in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or similar field required
  • Knowledge and experience with FDA regulatory aspects of prescription drug development end-to-end preferred.
  • Experience with various types of US submissions including generics preferred
  • Familiar with risk management program operations, including call center, database development and management, and effectiveness assessment required
  • Familiar with regulatory aspects at various stages of development, from entry-into-man to post approval activities required
  • Familiarity with clinical trial methodology and statistics preferred
  • Ability to influence within function, cross-functionally and globally
  • Excellent communication, social, negotiation and analytical skills
  • Ability to travel domestically occasionally and internationally, rarely


Please note that all information in this job description is accurate at the time of posting. Please be aware that companies may change details and/or closing dates without notice.


Job Summary

Johnson & Johnson
San Francisco
  • United States
  • Pharma/Biotech
Job Type
  • Full-time
  • Negotiable
25 April 2019
Applications Deadline
31 May 2019

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