Senior Medical Writer

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 as a Senior 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 :

• Receive medical writing projects and project information from the Senior Director, Medical Writing and Clinical Safety Monitoring. The project information includes, but is not limited to, the following : Type of medical writing project, e.g., clinical study report (CSR), scientific publication.Choice of document template or style / format guide or requirements.Study materials such as study protocol, statistical analysis plan, final study results (statistical tables, listings, and graphs).Similar reports or publications of previous similar studies.Literature references or other references such as Investigator’s Brochures, if available.Project milestones and timelines. As a Lead Senior Medical Writer, write clinical documents such as clinical study protocols, CSRs (full, abbreviated, or synoptic), DSURs, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts. With proper medical and study disease area experience, develop initial document shells or drafts using appropriate and approved templates and adhering to Everest or sponsor’s writing styles and formats.Provide appropriate and accurate interpretation of study results based on the provided background materials (e.g., study protocol, statistical analysis plan, Investigator’s Brochure, literature references) and statistical analysis output.Perform effective editing on assigned medical writing products to refine them, as much as possible and when time permits, before releasing them for internal and external review. Follow the Everest governing documents to obtain review comments on the document drafts from internal (Everest team) and external (sponsor staff) reviewers.Incorporate reviewers’ comments / input into the draft documents and deliver the revised documents for additional review cycle(s). Follow up on the quality control (QC) findings until they are properly addressed. Finalize documents for delivery to sponsors according to the established timelines. Manage all projects from initiation to close out of the project, ensuring on-time delivery and accuracy of the deliverable. Monitor and report on project progress for the assigned writing projects. Proactively identify and report issues or factors that potentially will impact the quality and timeliness of the medical writing projects.Act as the primary contact between Everest medical writing department and the clinical trial sponsors for assigned writing projects.Plan and coordinate internal QC, QA, and medical reviews of all deliverables, as applicable.Interact with Everest or sponsor Document Publishing Specialist, for the document publishing of the medical writing project, to ensure that the final medical writing product will meet specific document publishing requirements and timelines. Perform peer review for clinical documents developed by other Medical Writers, applying medical writing experience as well as therapeutic area and scientific knowledge in the review. Provide guidance to more junior Medical Writers.Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.Plan and carry out professional development.

Qualifications and Experience :

Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.At least five years' experience in medical writing practice in the pharmaceutical clinical trial environment.Experience with medical writing for clinical study reports for regulatory submission.Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.Excellent understanding of clinical trials and common clinical trial statistical analysis methods.Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.Experience with client relationship management.Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.Demonstrated experience, knowledge, and understanding of GCP / ICH guidelines, including E3 Structure and Content of Clinical Study Reports.Well organized and able to work independently.Comprehensive skills in MS Office applications and Adobe Acrobat. Computing skills with TRS Toolbox pharma edition plugin an asset.