Senior Medical Writer

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: As a Senior Medical Writer, author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, etc., and clinical trial activities. These documents include but are not limited to, briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, Clinical Study Reports (CSRs; full, abbreviated, or synoptic), Development Safety Update Reports (DSURs)/annual reports, and Investigator's Brochures (IBs). 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 plans and 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 and scientific 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. Interact with Everest or sponsor Document Publishers for the document publishing of the medical and scientific writing project, to ensure that the final writing product will meet specific document publishing requirements and timelines. Lead assigned writing projects from initiation to close out of the project. Act as the primary contact between Everest medical writing team and the sponsor, with a focus on client relationship management and quality deliverables. Monitor and report on project progress and proactively identify issues or factors that potentially will impact the quality and timeliness of the medical writing projects. Schedule document reviews by appropriate internal reviewers. Perform peer and quality control review for documents developed by other Medical Writers, applying medical and scientific writing experience as well as therapeutic area and scientific knowledge in the review. As a peer reviewer, further enhance the learning of the medical writer, providing feedback on the document and peer review findings. Contribute to the development and maintenance of standards for medical writing through participation in the development of related SOPs, guidelines, and good working practices. 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 5 years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment. Experience with preparing/authoring documents to support regulatory submissions including clinical trial authorizations and marketing authorization applications (preferred). Experience with medical writing of clinical and regulatory documents including briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, CSRs, DSURs/annual reports, and IBs. Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset (preferred). Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred). Demonstrated ability to understand medical information and results; able 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. 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. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, 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 sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $90,000 - $140,000.