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Senior Auditor, Clinical Quality And Compliance

5-10 years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🔍 Senior Auditor, Clinical Quality and Compliance
📍 Location: Canada
🕒 Job Type: Full-time

✨ Why Innovaderm?

As a Senior Auditor in Clinical Quality and Compliance, you'll be at the forefront of ensuring study conduct compliance and providing strong GxP consultation support. This is an ideal opportunity for someone who enjoys challenges, mentoring, and working with a small team.

🌟 Responsibilities

  • Implement audit plans and execute audits (site, studies, internal, vendors).
  • Lead and mentor audits and review audit reports.
  • Collaborate with the project management team to conduct clinical site audits.
  • Provide GxP consultation and support auditors in their activities.
  • Organize and host sponsor study audits, regulatory inspections, and mock inspections.
  • Contribute to the development of training materials related to SOPs, regulations, and GxP.

🎓 Requirements

  • Education: Bachelor’s degree in a relevant discipline or equivalent experience.
  • Experience: 5-10 years in the pharmaceutical or research industry, especially in clinical quality.
  • Skills:
    • In-depth knowledge of ICH guidelines, FDA, Health Canada, and EU regulations.
    • Expertise in the audit process and risk assessment.
    • Bilingual in French and English (oral and written).
    • Good organizational and communication skills.
    • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
    • Willing to travel 10-30% of the time.

💼 Benefits & Work Environment

  • Flexible work schedule
  • Permanent full-time position
  • Complete benefits: Medical, dental, vision, RRSP, vacation, personal days, and more.
  • Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
  • Ongoing learning and development

🏢 About Innovaderm

Innovaderm is a CRO specialized in dermatology, recognized for the quality of its research and services. Based in Montreal, Innovaderm continues to grow and expand across North America.

📩 How to Apply

Submit your application today, and our HR team will contact you if selected for an interview.

Innovaderm only accepts applicants with a work permit for Canada.