Sr Medical Writer, Redaction; Clinical Trial Transparency

Sr Medical Writer, Redaction (Clinical Trial Transparency)

• Authoring and Quality Assurance of Project Activities
• Marking /QC/Review and/or editing of pertinent documents such as:
  • Clinical study documents or any other documents for regulatory submission (e.g., clinical study reports, patient narratives, clinical summaries etc.) for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH)
  • Protocol and results summaries to support clinical trial disclosure commitments
  • Systematically perform quality control checks of documents prepared by colleagues against pre‑specified checklist generated in the project or SOP
  • Perform detailed analyses on a planned and ad‑hoc basis, relating to processes and their outputs
  • Ensure to abide with Client process
• Additional Activities
• Completion of Internal and Client specific training.
• Assist in mentoring and training of team members depending upon project requirement(s)

The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, company match 401(k), eligibility to participate in employee stock purchase plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

$80,600.00 - $

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Clinical Trial Disclosure plays a critically important role in executing projects for Syneos global clients. The role works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical, and technical information.