Project Manager, Marketed Product Risk Management, Janssen Inc. Toronto, ON-0459140723
Description
About Janssen Inc.
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 commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.
Position Overview
Janssen Inc. is looking for a Project Manager, Marketed Product Risk Management (MPRM) at our Toronto, Ontario location. As part of the Regulatory, Quality, Marketed Product Risk Management, and Safety (RQMS) Division, the MPRM group works closely with Regulatory Affairs and Drug Safety & Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs) and to contribute to the development of drug surveillance and risk mitigation activities under RMP commitments, including educational initiatives, post-market studies, and market surveys.
Key Responsibilities
• Plan, prepare, deliver and maintain Risk Management Plans (RMPs) and addenda in compliance with Health Canada requirements and in alignment with the company’s business objectives
• Liaise with Regulatory Affairs to assess requirements for RMPs in relation to regulatory submission activities
• Collaborate with the MPRM Manager and local and global cross-functional teams on the development of risk mitigation strategies
· 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 the effectiveness of implemented risk mitigation initiatives
• 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
• Prepare responses to Health Canada questions related to RMPs and related safety issues
• Proactively monitor proposed changes in regulations and guidelines, assess impact, and provide feedback to the business partners
· Provide education and training to business partners, as required
Qualifications
• University degree in Pharmacy or Nursing; MSc, Ph.D. or PharmD, with 3-5 years of relevant experience in pharmaceutical regulatory affairs or drug safety
• Strong scientific writing skills, with experience authoring clinical safety or regulatory documents an asset
• Ability to interpret clinical data and to summarize and synthesize arguments
• Well-developed project management skills
• Well-developed team skills
• Ability to manage multiple priorities
• Strong negotiation and influencing skills
• Refined problem solving and analytical skills
• Excellent communication skills (written and verbal, including presentation skills)
· Background in Pharmacovigilance, safety signal detection/signal work-up an asset
• Therapeutic area knowledge in immunology, oncology, infectious diseases, neuroscience, or metabolic diseases an asset
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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 have the opportunity to achieve their potential.
J2W LI NA
Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Drug & Product Safety Operations
Description
About Janssen Inc.
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 commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.
Position Overview
Janssen Inc. is looking for a Project Manager, Marketed Product Risk Management (MPRM) at our Toronto, Ontario location. As part of the Regulatory, Quality, Marketed Product Risk Management, and Safety (RQMS) Division, the MPRM group works closely with Regulatory Affairs and Drug Safety & Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs) and to contribute to the development of drug surveillance and risk mitigation activities under RMP commitments, including educational initiatives, post-market studies, and market surveys.
Key Responsibilities
• Plan, prepare, deliver and maintain Risk Management Plans (RMPs) and addenda in compliance with Health Canada requirements and in alignment with the company’s business objectives
• Liaise with Regulatory Affairs to assess requirements for RMPs in relation to regulatory submission activities
• Collaborate with the MPRM Manager and local and global cross-functional teams on the development of risk mitigation strategies
· 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 the effectiveness of implemented risk mitigation initiatives
• 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
• Prepare responses to Health Canada questions related to RMPs and related safety issues
• Proactively monitor proposed changes in regulations and guidelines, assess impact, and provide feedback to the business partners
· Provide education and training to business partners, as required
Qualifications
• University degree in Pharmacy or Nursing; MSc, Ph.D. or PharmD, with 3-5 years of relevant experience in pharmaceutical regulatory affairs or drug safety
• Strong scientific writing skills, with experience authoring clinical safety or regulatory documents an asset
• Ability to interpret clinical data and to summarize and synthesize arguments
• Well-developed project management skills
• Well-developed team skills
• Ability to manage multiple priorities
• Strong negotiation and influencing skills
• Refined problem solving and analytical skills
• Excellent communication skills (written and verbal, including presentation skills)
· Background in Pharmacovigilance, safety signal detection/signal work-up an asset
• Therapeutic area knowledge in immunology, oncology, infectious diseases, neuroscience, or metabolic diseases an asset
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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 have the opportunity to achieve their potential.
J2W LI NA
Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Drug & Product Safety Operations