Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that's us...that's Everest.
To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.
Key Accountabilities
1. Medical Writing and Regulatory Support
- Author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, and clinical trial activities (e.g., briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, CSRs, DSURs/annual reports, and IBs).
- Develop initial document shells or drafts using appropriate templates and adhering to writing styles.
- Provide accurate interpretation of study plans and results based on background materials and statistical output.
- Perform effective editing and incorporate reviewer comments/input into draft documents.
- Finalize documents for delivery to sponsors according to established timelines.
- Interact with Document Publishers to ensure final products meet specific requirements.
2. Project Leadership
- Lead assigned writing projects from initiation to close out.
- Act as the primary contact between the medical writing team and the sponsor.
- Monitor and report on project progress, proactively identifying issues impacting quality or timelines.
- Schedule document reviews by appropriate internal reviewers.
3. Quality and Standards
- Perform peer and quality control reviews for documents developed by other Medical Writers.
- Contribute to the development and maintenance of standards for medical writing (SOPs, guidelines).
- Keep current on training of Everest Guidance Documents and regulatory requirements (ICH).
- Plan and carry out professional development.
Qualifications and Experience
- Advanced degree (Ph.D. preferred) in Clinical, Medical, or Life Sciences, or Master's degree with substantial experience.
- At least 5 years' experience in medical writing practice within a pharmaceutical clinical trial environment.
- Experience preparing documents to support regulatory submissions (preferred).
- Experience with clinical and regulatory documents (briefing packages, CSRs, IBs, etc.).
- Experience in multiple therapeutic areas and Phase I through IV clinical trials (preferred).
- Excellent understanding of clinical trials and statistical analysis methods (preferred).
- Demonstrated ability to communicate effectively, orally and in writing.
- Ability to handle multiple projects and clients.
- Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
- Knowledge of GCP/ICH guidelines, including E3.
- Well organized and able to work independently.
- Comprehensive skills in MS Office and Adobe Acrobat.
Benefits & Compensation
We offer a robust benefits package including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off, and the opportunity to earn a performance-based bonus.
Estimated Salary Range: $90,000 - $140,000.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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