Associate, Drug Safety Risk Management

2 weeks ago

Toronto, Canada Johnson & Johnson Full time

Janssen Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate, Drug Safety Risk Management located in Toronto, Canada. Please Note: This role will align with the Flexible Working Model - 2 days remote and 3 days in the office.

As part of the Risk Management team, the Associate, Drug Safety Risk Management will work in collaboration with Drug Regulatory Affairs and Drug Safety and Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs) across multiple therapeutic areas. This individual will also support teams working on the development of surveillance and risk mitigation activities under RMP commitments, including educational initiatives, controlled distribution programs, post-market studies, and market surveys.

Principal Responsibilities:

- Plan, prepare, deliver, and maintain drug product RMPs and Canadian Addenda in compliance with Health Canada requirements and in alignment with the company’s business objectives.
- Work collaboratively with drug Regulatory Affairs to assess requirements for RMPs to support regulatory submission activities.
- Collaborate with local and global cross-functional teams on the development of risk mitigation strategies and activities.
- Track the implementation of risk management programs with all contributing departments to ensure adherence to deliverables and timelines proposed in regulatory submissions.
- Contribute to the assessment of effectiveness in risk mitigation activities.
- Review safety documentation, including Periodic Safety Update Reports (PSURs) and Company Core Data Sheet (CCDS) updates, to assess impact of any changes to these documents on the risk management strategies for planned RMPs.
- Support the preparation of responses to Health Canada questions about RMPs and related safety issues, including Issue-related Summary Reports (IRSRs), to meet all Canadian regulatory requirements.
- Contribute to company and industry association policy activities to shape the Canadian regulatory environment for RMPs and post-market safety requirements.

**Qualifications**:

- A minimum of a Bachelor’s degree in a scientific, medical or health-related discipline is required. Advanced degree (Master’s PharmD, Ph.D.) in a scientific, medical or health-related discipline is preferred.
- Formal education, such as a Post Graduate diploma, or experience in Pharmaceutical Regulatory Affairs is preferred.
- Professional certification in drug Regulatory Affairs is preferred.
- Experience authoring regulatory, clinical and/or drug safety documents required.
- Experience in preparing regulatory documentation for submission to Health Canada is preferred.
- Strong scientific and medical writing skills required.
- Experience in the authoring of scientific publications is preferred.
- Strong project management skills required.
- Experience in clinical/epidemiological research, pharmacovigilance, or pharmacokinetics is preferred.
- Understanding of data analysis methodology or biostatistics is preferred.
- Experience in the following Therapeutic Areas preferred: Immunology, Oncology, Infectious Diseases, Neuroscience, Metabolic Diseases.
- Must have excellent communication (written and verbal) and presentation skills.
- Must have strong problem-solving and analytical skills.
- Must have strong negotiation skills.
- The ability to handle multiple priorities and deadlines is required.
- The ability to interpret and summarize clinical data and to synthesize arguments is required.
- The ability to collaborate with stakeholders and influence decision-making in a cross-functional team environment.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.

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