Clinical Writer Regulatory Submissions

Position: Clinical Writer for Regulatory Submissions
Join Syneos Health as a Clinical Writer, focusing on regulatory submissions for clinical trials.

Your role will encompass document quality assurance and mentoring team members.

In the position of Clinical Writer with Syneos Health, you will play a crucial role in authoring and ensuring the quality of regulatory documents related to clinical trials. Responsibilities include reviewing clinical study documents, performing quality control checks, and assisting in protocol summaries. You will lead efforts in compliance with rigorous regulatory standards while mentoring incoming team members.

Key Responsibilities:

• Quality assurance of clinical study reports and narratives

• Edit and review regulatory submission documents

• Conduct systematic quality checks against project checklists

• Perform in-depth analysis of clinical processes and documents

• Facilitate training for team members depending on project needs

Requirements:

• Experience in medical writing or related field

• Knowledge of EMA and Health Canada regulations

• Detail-oriented with strong analytical abilities

• Proficient in writing complex medical and technical documents

• Willingness to engage in continuous training

Leverage your writing skills to ensure clarity and compliance in clinical trials at Syneos Health.
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