Medical Writer

🔥 14 hours ago

🇨🇦 Canada – Remote

💵 $65k - $100k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥📝 Medical Writer

👻 Ghost score 0%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Work closely with Everest project team members to achieve project milestones according to project timelines • Perform internal QC procedures for clinical documents, including protocols, CSRs, PK reports, statistical reports, integrated summaries, patient narratives, manuscripts, posters, and abstracts • Check tables of contents, lists of tables and figures, abbreviations, protocol-related information, in-text numbers, source references, Word styles, quoted references, and appendices • Act as lead medical writer in preparing clinical documents and scientific publications • Develop document shells or drafts using approved templates and Everest or Sponsor writing styles • Interpret study results using protocols, statistical analysis plans, investigator brochures, literature references, and statistical outputs • Edit medical writing products before internal and external review • Obtain and incorporate internal and Sponsor review comments • Follow up on QC findings and finalize documents for Sponsor delivery • Perform literature searches to support senior medical writers • E-publish CSRs and other clinical/regulatory documents, including PDF rendering, hyperlinking, bookmarking, table-of-contents updates, and pagination • Assemble and package TLGs into Word and PDF formats • May serve as DMC Administrator or Secretary, coordinating charters, meetings, minutes, recommendations, committee liaison activities, members, agreements, honoraria, and data reports • Plan and manage deliverables and timelines • Maintain training on Everest Guidance Documents and pharmaceutical trial regulator and ICH requirements • Plan and carry out professional development

🎯 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) • a pension plan • generous paid time off and sick leave • opportunity to earn a performance based bonus