Medical Writer

Everest Clinical Research; Markham; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

An established industry player in clinical research is on the lookout for a dedicated Medical Writer to enhance their team. This role involves preparing critical clinical documents and ensuring they meet the highest standards of quality and accuracy. You'll collaborate with project teams, manage multiple projects, and engage in professional development. With a commitment to excellence and a focus on customer satisfaction, this innovative organization offers an exciting opportunity to work in a dynamic environment that values your contributions. Join a forward-thinking firm that prioritizes quality and flexibility in the ever-evolving field of clinical research.

Qualifications

• Advanced degree in Clinical, Medical, or Life Sciences preferred.
• Minimum of two years' experience in medical writing.

Responsibilities

• Prepare clinical documents and scientific publications.
• Perform internal QC procedures for clinical documents.
• Manage project deliverables and timelines.

Skills

Medical Writing

Clinical Trials Knowledge

Statistical Analysis

Excellent Communication Skills

Project Management

Education

Ph.D. in Clinical, Medical, or Life Sciences

Master's Degree with Relevant Experience

Tools

Microsoft Office

Adobe Acrobat

TRS Toolbox Pharma Plugin

Job description

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 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 team as a Medical Writer 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. Work closely with project team members to achieve project milestones according to the timeline.
2. Perform internal QC procedures for clinical documents, including protocols, CSRs, pharmacokinetic reports, statistical reports, efficacy/safety summaries, manuscripts, posters, and abstracts. Ensure accuracy, consistency, and adherence to style and format standards.
3. Act as a lead medical writer in preparing clinical documents or scientific publications, developing drafts, interpreting study results, editing, and incorporating reviewer comments.
4. Perform literature searches to support senior medical writers.
5. Perform document e-publishing for CSRs and other clinical/regulatory documents, ensuring they meet publishing requirements and timelines.
6. Manage the assembly and packaging of TLGs into Word and PDF formats for departmental teams, potentially serving as a lead.
7. Serve as DMC Administrator and/or Secretary, performing administrative tasks such as drafting charters, coordinating meetings, and managing committee communications.
8. Plan and manage deliverables and timelines in accordance with project requirements.
9. Stay current on training and guidelines issued by regulatory authorities and ICH.
10. Engage in ongoing professional development activities.

Qualifications and Experience:

• Advanced degree (Ph.D. preferred) in Clinical, Medical, or Life Sciences; or a Master’s degree with substantial relevant experience.
• Minimum of two years' experience in medical writing within the pharmaceutical clinical trial environment.
• Experience with clinical study reports for regulatory submissions is preferred.
• Experience across multiple therapeutic areas and phases (I-IV) is an asset.
• Strong understanding of clinical trials and statistical analysis methods.
• Excellent communication skills, both oral and written.
• Ability to manage multiple projects efficiently.
• Team-oriented with attention to detail, customer focus, and quality orientation.
• Knowledge of GCP/ICH guidelines, especially E3 structure and content of CSRs.
• Proficiency in Microsoft Office and Adobe Acrobat; experience with TRS Toolbox pharma plugin is a plus.

For more information about Everest Clinical Research and other opportunities, visit our website.

We appreciate all applicants; only those selected for an interview will be contacted. Everest is committed to diversity and equal opportunity, welcoming applications from people with disabilities and providing accommodations upon request.