Project Manager, Pharmaceutical Regulatory Medical Writing & Risk Management (contract)

Job description

Janssen Inc. is looking to hire a Project Manager, Pharmaceutical Regulatory Medical Writing & Risk Management in Toronto, Ontario. This role is 12-month contractual position.

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women's health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.

Position Overview

As part of the Regulatory, Quality, Marketed Product Risk Management, and Safety (RQMS) Division, our team works closely with drug Regulatory Affairs and Drug Safety & Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs), respond to Health Canada queries and 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, write, deliver and maintain drug product Risk Management Plans (RMPs) and addenda in compliance with Health Canada requirements and in alignment with the company's business objectives
· Liaise with drug Regulatory Affairs to assess requirements for RMPs in relation to 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
· Prepare responses to Health Canada questions related to drug product RMPs and related safety issues, including Issue-related Summary Reports (IRSRs) meeting Canadian regulatory requirements
· Contribute to company and industry association policy activities to shape the Canadian regulatory environment for RMPs and post-market safety requirements
· Provide education and training to business partners, as required

Desired profile

Qualifications :

·  A minimum of a B.Sc. is required (Nursing and Pharmacy preferred); M.Sc., Ph.D. or Pharm D is an asset.
·  A minimum of 2 years of relevant experience in pharmaceutical regulatory affairs or medical writing
·  Strong scientific writing skills, with experience authoring clinical, drug safety or regulatory documents is required.
·  Background in regulatory affairs, clinical/epidemiological research, pharmacovigilance, safety signal detection/work-up is an asset
·  Ability to interpret and summarize clinical data and to synthesize arguments
·  Experienced with leading projects from inception to completion is required.
·  Ability to manage multiple priorities and deadlines
·  Strong negotiation and influencing skills
·  Experience in the planning or conducting clinical/epidemiological research studies an asset
·  Therapeutic area knowledge in immunology, oncology, infectious diseases, neuroscience, or metabolic diseases an asset 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.