Exemplar Global Career Center

Associate Regulatory Risk Management (12-month contract)

Johnson & Johnson
Toronto, Canada
12 days ago

Description

Janssen Inc., is currently seeking an Associate, Regulatory Risk Management on a 12-month contract. This role will be based out of our office in Toronto, CA.

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 www.janssen.com and follow us @JanssenGlobal. Janssen Inc, is part of the Janssen Pharmaceutical Companies.

As a member of the Johnson & Johnson Family of Companies, Janssen Inc. is the pharmaceutical sector and is dedicated to addressing and solving the most important unmet medical needs in oncology, immunology, infectious diseases and vaccines, neuroscience, metabolic diseases, and women's health. Driven by our dedication to the hardworking pursuit of science for the benefit of patients, we work together to bring creative ideas, products and services to patients around the world.

As part of the Regulatory, Quality, Marketed Products Risk Management, and Safety (RQMS) Division, the contractual Associate, Regulatory Risk Management works in collaboration with Drug Regulatory Affairs and Drug Safety & Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs) across multiple therapeutic areas. Regulatory Risk Management also contributes to the development of surveillance and risk mitigation activities under RMP commitments, including educational initiatives, post-market studies, and market surveys.

In this role, you will:
  • Plan, prepare, deliver and maintain drug product Risk Management Plans (RMPs) and Canadian Addenda in compliance with Health Canada requirements and in alignment with the company's business objectives
  • Collaborate closely 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
  • Coordinate and 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

Education:
  • Minimum B.Sc. in a relevant scientific or medical field (required)
  • A degree in Pharmacy, Nursing or a health-related field
  • A Ph.D., Pharm D or M.Sc. in a relevant scientific or medical field
  • Formal education or experience in pharmaceutical Regulatory Affairs (preferred)
  • Formal education, such as a Post Graduate Diploma in pharmaceutical Regulatory Affairs (preferred)


Required Skills:
  • Strong scientific and medical writing skills, with experience authoring regulatory, clinical and/or drug safety documents
  • Ability to interpret and summarize clinical data and to synthesize arguments
  • Well-developed project management skills
  • Well-developed team skills
  • Ability to handle multiple priorities and deadlines
  • Strong negotiation and influencing skills
  • Problem solving and analytical skills
  • Excellent communication skills (written and verbal, including presentation skills)


Preferred Skills:
  • Experience in preparing regulatory documentation for submission to Health Canada
  • Confirmed experience in pharmaceutical Regulatory Affairs
  • Professional certification in drug Regulatory Affairs
  • Background in clinical/epidemiological research, pharmacovigilance, or pharmacokinetics
  • An understanding of data analysis methodology or biostatistics
  • Experience in authoring of scientific publications
  • Therapeutic area knowledge in immunology, oncology, infectious diseases, neuroscience, or metabolic diseases


At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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

Primary Location
Canada-Ontario-Toronto-19 Green Belt Drive
Organization
Janssen Inc. (7710)
Job Function
Regulatory Affairs
Requisition ID
2206013681W

Job Information

  • Job ID: 63221113
  • Location:
    Toronto, Canada
  • Position Title: Associate Regulatory Risk Management (12-month contract)
  • Company Name For Job: Johnson & Johnson
  • Job Function: Other

Please refer to the company's website or job descriptions to learn more about them.

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