Senior Medical Writer Regulatory Expertise

Position: Senior Medical Writer with Regulatory Expertise
Elevate clinical documentation as a Senior Medical Writer at Precision Medicine Group. Lead development in compliance with industry standards, enhancing study quality and efficiency.

In this role, you will capitalize on your 5+ years of medical writing experience, leading the creation of essential clinical documents across various studies. Your responsibilities will include writing, editing, and ensuring the timely delivery of high-quality documents that meet regulatory requirements. Strong writing and verbal communication skills will enable you to work effectively with internal and external teams.

Key Responsibilities:

• Plan and produce clinical documents per regulatory guidelines

• Ensure document lifecycle is executed smoothly

• Distill clinical data into clear written content

• Maintain and enhance medical writing processes

• Engage in research to substantiate writing efforts

Requirements:

• BS degree in a relevant scientific field

• 5+ years as a medical writer in CRO/sponsor settings

• Proficiency in Microsoft and Adobe software

• Thorough knowledge of ICH, FDA, and GCP

• Impeccable attention to detail and ability to meet deadlines

Unlock your potential in medical writing with Precision Medicine and drive impactful clinical studies.
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