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Medical Writer
Everest Clinical ResearchMedical Writer at Everest Clinical Research involved in developing clinical documents and ensuring quality control. Collaborating with project teams and preparing reports in line with regulations and study protocols.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- Perform document e-publishing for CSRs and other clinical/regulatory documents.
Requirements
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical study reportsliterature searchesdocument e-publishingstatistical analysis methodsQC procedurestherapeutic area experienceclinical trial experienceGCP/ICH guidelinesPhase I through IV clinical trials
Soft Skills
communication skillsinterpersonal skillsteamwork skillsdetail-orientedcustomer-focusedquality-focusedorganizational skillsability to handle multiple projectsindependent workability to understand medical information
Certifications
Ph.D. in Clinical or Medical or Life SciencesMaster’s degree in relevant field