Sr Medical Writer, Redaction; Clinical Trial Transparency
Syneos Health/ inVentiv Health Commercial LLC
Behavioral Health Market Context
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Benefits
Salary Range: $80,600.00 - $BenefitsCompany car or car allowanceMedical, dental, and vision health benefitsCompany‑matched 401(k)Eligibility to participate in the Employee Stock Purchase PlanEligibility to earn commissions/bonuses based on company and individual performanceFlexible paid time off (PTO) and sick timeCompliance with all applicable federal, state, and municipal paid sick time requirements6 more items(s)
Responsibilities
- •Authoring and Quality Assurance of Project Activities
- •Execute project‐specific activities with high quality and within defined timelines according to standard processes and operating procedures
- •Marking, QC, review, or editing of pertinent documents including:
- •Clinical study documents or other documents for regulatory submission (e.g., clinical study reports, patient narratives, clinical summaries for EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule‑NIH)
- •Protocol and results summaries to support clinical trial disclosure commitments
- •Quality control checks of documents prepared by colleagues against pre‑specified checklists or SOPs
- •Detailed analyses on a planned and ad‑hoc basis, relating to processes and their outputs
- •Ensuring compliance with client processes
- •Completion of internal and client‑specific training
- •Assisting in mentoring and training of team members depending upon project requirements
- •7 more items(s)
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