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Medical Writer
Everest Clinical Research. Work closely with Everest project team members to achieve project milestones according to project timelines .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing for clinical documents and regulatory submissions, with a strong understanding of clinical trials and statistical analysis methods. Proficient in managing project timelines and deliverables while ensuring quality and compliance with GCP/ICH guidelines.
Highest-signal resume keywords
Medical WritingClinical Study ReportsGCP/ICH GuidelinesStatistical Analysis MethodsProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Medical WritingClinical Study ReportsStatistical AnalysisLiterature SearchesDocument EditingQC ProceduresE-PublishingDocument DraftingRegulatory SubmissionTherapeutic Areas Knowledge
Soft Skills
Effective CommunicationInterpersonal SkillsDetail-OrientedTeamworkCustomer Focus
Tools & Technologies
Microsoft OfficeAdobe AcrobatTRS Toolbox Pharma Edition
Industry Keywords
Clinical TrialsPharmaceuticalsICH RequirementsGCP GuidelinesPhase I-IV Trials
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
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)
- a pension plan
- generous paid time off and sick leave
- opportunity to earn a performance based bonus