Senior Medical Writer - Late Phase

Join Syneos Health as a Senior Medical Writer specializing in late-phase regulatory documents. Leverage your CSR and protocol writing expertise to influence critical changes in clinical research.

In this pivotal role, you will author vital regulatory submissions such as IND and NDA documents. Collaborate with cross-functional teams while mentoring less experienced writers on complex projects. Your ability to ensure compliance with regulatory standards and foster a culture of continuous improvement will be at the forefront of this position.

Key Responsibilities:

• Author clinical study protocols and reports

• Manage writing activities across various departments

• Ensure compliance with regulatory standards

• Conduct document reviews for accuracy

• Refine internal writing processes for effectiveness

Requirements:

• Proven clinical research document writing experience

• Strong knowledge of ICH guidelines and procedures

• Exceptional editing and review abilities

• Build collaborative relationships across teams

• Work effectively within project budgets and timelines

Deliver impactful regulatory writing and mentorship to enhance Syneos Health’s late-phase studies.
#J-18808-Ljbffr