Associate Regulatory Risk Management

  • Full Time
  • View on Map
  • posted 1 month ago
  • Posted : January 4, 2023 -Accepting applications
  • Salary: $87,000.00 - $95,000.00 / per year
  • View(s) 708

Job Detail

  • Job ID 15056

Job Description

Merit Services is looking for an experienced Associate Regulatory Risk Management professional.

RESPONSIBILITIES

‣ 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 the 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

REQUIRED

‣ Strong scientific and medical writing skills, with experience authoring regulatory, clinical, and/or drug safety documents

‣ Ability to interpret and summarize clinical data and 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

‣ 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 the authoring scientific publications

‣ Therapeutic area knowledge in immunology, oncology, infectious diseases, neuroscience, or metabolic diseases

Required skills

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