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Regulatory Affairs Group

Associate, Drug Safety Risk Management

  • Titel Associate, Drug Safety Risk Management
  • Functie Regulatory Affairs Group
  • Sub functie Regulatory Affairs
  • Categorie Experienced Analyst, Regulatory Affairs (P5)
  • Locatie Toronto, Ontario, Canada
  • Gepost
  • Referentie 2406182435W
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Beschrijving

Johnson & Johnson company, is currently seeking 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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  https://www.jnj.com/.  

As part of the Drug Safety Risk Management team at our Toronto, Ontario location, the Associate, Drug Safety Risk Management works in collaboration with Regulatory Affairs and Drug Safety & Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs) across multiple therapeutic areas. The Associate, Drug Safety Risk Management also supports 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.

Key Responsibilities:

  • Plan, prepare, deliver, and maintain drug product local Risk Management Plans (RMPs) and Canadian Addenda in compliance with Health Canada requirements and in alignment with the company’s business objectives
  • Work collaboratively with Regulatory Affairs to assess requirements for RMPs to support regulatory submission activities
  • Collaborate with local and/or global cross-functional teams on the development of risk mitigation strategies
  • Review risk minimization tools to ensure adherence to deliverables proposed in regulatory submissions and Canadian Addenda for additional risk minimization activities (ARMAs)
  • Complete reporting of [core] additional risk minimization activities ([C]ARMAs) and local ARMAs in global tracking systems
  • Review safety documentation, including Periodic Safety Update Reports, Canadian Product Monograph updates, and core RMP and European Union RMP updates to assess the impact of any changes to these documents on the risk management strategies for Canadian Addenda or local RMPs
  • Support the preparation of responses to Health Canada questions about RMPs and related safety issues, including Issue-related Summary Reports 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

Kwalificaties

  • Minimum B.Sc. in a relevant scientific or medical field is required with at least 2 years of relevant work experience, in drug Regulatory Affairs or in drug Safety/Pharmacovigilance in a pharmaceutical or biotechnology company
  • A degree in Pharmacy, Nursing or a health-related field (preferred)
  • An advanced degree (e.g., Ph.D., Pharm D or M.Sc.) in a relevant scientific or medical field (preferred)
  • Formal education or experience in pharmaceutical Regulatory Affairs (preferred)
  • Formal education, such as a Post Graduate Diploma in pharmaceutical Regulatory Affairs (preferred)

Experience and Skills:

Required:

  • Strong scientific and medical writing skills (in English), with experience authoring regulatory, clinical and/or drug safety documents
  • Ability to interpret and summarize clinical data and to synthesize arguments is required
  • Well-developed project management skills
  • Well-developed team skills; promoting inclusive, transparent, and constructive input from collaborators
  • Ability to prioritize, manage multiple competing priorities and deliver on objectives
  • High standards of ethics and compliance to regulatory and legal requirements
  • Excellent communication skills (written and verbal, including presentation skills)

Preferred:

  • Experience in preparing regulatory documentation for submission to Health Canada
  • Experience in preparing drug risk management plans and/or Canadian Addenda for submission to Health Canada
  • Therapeutic area knowledge in immunology, oncology, infectious diseases, vaccines, neuroscience, pulmonary hypertension, or metabolic diseases

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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