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Medical Writer
Location
Canada
Posted
83 days ago
Salary
$65K - $100K / year
Seniority
Mid Level
Job Description
Medical Writer
Everest Clinical Research
• 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, and 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. • Document publishing activities include, but are not limited to the following: Rendering the completed final Word report to PDF. • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
Job Requirements
- 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.
Benefits
- 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
- performance based bonus
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