Clinical Research Document Specialist
1 week ago
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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