Medical Writer

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

📋 Description

• Collaborate closely with the Everest project team members designated for the project to meet project milestones as per the established timeline.

• Execute internal quality control procedures for clinical documents crafted by other Medical Writers, including 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.

• Utilize therapeutic area expertise and scientific knowledge to conduct reviews and implement quality checks for protocol-related information, the accuracy of in-text numbers and source references, as well as the consistency of document styles and formats.

• Serve as the lead medical writer for the development of clinical documents or scientific publications.

• Conduct literature searches to assist senior medical writers.

• Carry out document e-publishing for CSRs and other clinical/regulatory documents.

⛳️ Requirements

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

• A minimum of two years' 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 Phase I through IV clinical trials is advantageous.

• Strong understanding of clinical trials and commonly used clinical trial statistical analysis methods is preferred.

• Proven ability to comprehend medical information and results; effective communication skills, both oral and written.

• Capacity to manage multiple projects and clients simultaneously.

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

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

• Highly organized and capable of working independently.

• Proficient in Microsoft Office applications and Adobe Acrobat.

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

🏝️ 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

• Opportunity to earn a performance-based bonus