Clinical Research Document Specialist

1 week ago


Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Description

Job Title: Clinical Research Document Specialist

Company: Everest Clinical Research Services Inc

Location: Remote or Toronto/Markham, Ontario, Canada

Job Type: Full-time

About Us:

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing clinical research services to pharmaceutical, biotechnology, and medical device industries. We are committed to delivering high-quality clinical trial data and regulatory submissions.

About the Role:

We are seeking an experienced Clinical Research Document Specialist to join our team. The ideal candidate will have a strong background in medical writing, regulatory submissions, and clinical trials documentation.

Key Responsibilities:

  • Develop and maintain clinical documents, including clinical study reports, regulatory submissions, and study protocols.
  • Collaborate with cross-functional teams to ensure timely and accurate delivery of clinical documents.
  • Review and revise clinical documents to ensure compliance with regulatory requirements.
  • Provide support for regulatory submissions, including preparation of regulatory documents and responses to agency queries.

Requirements:

  • Advanced degree in a life science or related field.
  • Minimum 2 years of experience in medical writing, regulatory submissions, or clinical trials documentation.
  • Strong understanding of regulatory requirements, including ICH and GCP guidelines.
  • Excellent writing and communication skills.
  • Ability to work independently and collaboratively as part of a team.

What We Offer:

Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and dynamic work environment.



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