Medical Writer

This is a fully remote position, open to applicants in Canada.

📋 Description

• Collaborate closely with the Everest project team to meet project milestones within established timelines.

• Execute internal quality control procedures for clinical documents, which include protocols, clinical study reports (CSRs), pharmacokinetic reports, statistical reports, integrated summaries, patient narratives, manuscripts, posters, and abstracts.

• Review tables of contents, lists of tables and figures, abbreviations, protocol-related information, in-text numbers, source references, Word styles, quoted references, and appendices.

• Serve as the lead medical writer for the creation of clinical documents and scientific publications.

• Create document shells or drafts utilizing approved templates and adhering to Everest or Sponsor writing styles.

• Analyze study results by referencing protocols, statistical analysis plans, investigator brochures, literature references, and statistical outputs.

• Edit medical writing products prior to internal and external review.

• Gather and integrate feedback from internal and Sponsor reviews.

• Address quality control findings and finalize documents for delivery to the Sponsor.

• Conduct literature searches to assist senior medical writers.

• E-publish clinical study reports and other clinical/regulatory documents, which includes PDF rendering, hyperlinking, bookmarking, updating table of contents, and pagination.

• Compile and format tables, listings, and graphs (TLGs) into Word and PDF formats.

• May take on the role of DMC Administrator or Secretary, managing charters, meetings, minutes, recommendations, committee liaison activities, member agreements, honoraria, and data reports.

• Organize and oversee deliverables and timelines.

• Keep current with training on Everest Guidance Documents and pharmaceutical trial regulations, including ICH requirements.

• Plan and execute professional development activities.

⛳️ Requirements

• An advanced degree, preferably a Ph.D., in Clinical, Medical, or Life Sciences, or a Master’s degree with significant experience in the relevant field.

• A minimum of two years of experience in medical writing, particularly within the pharmaceutical clinical trial setting.

• Experience in medical writing for clinical study reports intended for regulatory submission is preferred.

• Familiarity with multiple therapeutic areas and clinical trials spanning Phase I to IV is advantageous.

• Strong understanding of clinical trials and common statistical analysis methods used in clinical research is preferred.

• Proven ability to comprehend medical information and outcomes; capable of communicating effectively both orally and in writing.

• Ability to manage multiple projects and clients simultaneously.

• Exceptional interpersonal and teamwork skills; detail-oriented, with a focus on customer satisfaction and quality.

• Demonstrated experience and knowledge of GCP/ICH guidelines, including the E3 Structure and Content of Clinical Study Reports.

• Highly organized and able to work independently.

• Proficient in Microsoft Office applications and Adobe Acrobat.

• Computing skills with the TRS Toolbox pharma edition plugin are a plus.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life and Accidental Death & Dismemberment (AD&D) insurance.

• Short-term and long-term disability coverage.

• Tuition reimbursement program.

• Fitness reimbursement options.

• Employee assistance program (EAP).

• Pension plan availability.

• Generous paid time off and sick leave policies.

• Opportunity to earn a performance-based bonus.