Regulatory Medical Writer - Late Phase

Become a vital part of Syneos Health as a Senior Medical Writer specialized in late-phase regulatory documentation. Your skills in CSR and protocol writing can drive pivotal change.
As a Senior Medical Writer, you'll play a critical role in the development of medical documents for various studies. Your experience in authoring important regulatory submissions like IND and NDA will be essential. Collaborate with diverse teams to ensure that all written materials adhere to established guidelines while mentoring less experienced writers on complex projects, fostering a culture of continuous improvement.

Key Responsibilities:

• Author clinical study protocols, reports, and safety documents

• Manage and coordinate writing activities across departments

• Ensure compliance with client and regulatory standards

• Conduct document reviews and quality checks for accuracy

• Develop and refine internal writing processes
Requirements:

• Proven experience in writing clinical research documents

• Strong knowledge of ICH guidelines and regulatory procedures

• Exceptional editing and review skills

• Ability to build collaborative relationships

• Capable of working within project budgets and timelines
Use your medical writing proficiency to transform the patient care landscape at Syneos Health.
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