Medical Writer

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🕒 March 27

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

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 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.

🎯 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