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Medical Writer
Location
Canada
Posted
15 days ago
Salary
C$65K - C$100K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Medical Writer
Everest Clinical Research
Role Description 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 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. - Work closely with the Everest project team members assigned to the project to achieve project milestones according to the project timeline. - Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as: - Clinical study protocols - Clinical Study Reports (CSRs; full, abbreviated, or synoptic) - Pharmacokinetic (PK) reports - Statistical reports - Integrated efficacy or safety summaries - Patient narratives - Manuscripts, posters, and abstracts - Apply therapeutic area experience and scientific knowledge in the review and include QC checks for: - Protocol-related information - Accuracy of in-text numbers and source references - Consistency of document styles and formats - Act as a lead medical writer in the preparation of clinical documents or scientific publications. - Perform literature searches to support senior medical writers. - Perform document e-publishing for CSRs and other clinical/regulatory documents. - Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements. - 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 - 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 two years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment. - Experience with medical writing for clinical study reports for regulatory submission (preferred). - 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 Microsoft Office applications and Adobe Acrobat. Computing skills with TRS Toolbox pharma edition plugin an asset. Requirements - Strong foundation in statistical and data management. - Ability to perform effective editing on assigned medical writing products. - Experience in performing QC checks on medical writing deliverables. - Ability to incorporate reviewers’ comments/input into draft documents. - Experience in finalizing documents for delivery to Sponsors according to established timelines. Benefits - 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). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus.
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