Consultant I, Medical Writing

Responsibilities

• Author regulatory documents including Clinical Study Reports, study protocols and client submission materials

• Lead development of complex modules such as Module 2 summaries and briefing documents

• Apply quality control and submission-readiness processes within client timelines

• Serve as project owner by tracking timelines and coordinating with clients

• Facilitate client interactions including meetings and feedback discussions

• Collaborate with cross-functional teams on regulatory document quality and accuracy

• Contribute to regulatory strategies for early-stage and smaller clients

Requirements

• 3+ years industry experience

• Proficiency in Microsoft Office, Teams and MS Project

• Familiarity with regulatory document management systems such as Veeva Vault

• Experience with regulatory submissions and global regulatory standards

• Strong foundation in medical and regulatory writing

• Effective written and verbal communication skills

• Strong critical thinking and attention to detail

Preferred Qualifications

• Advanced degree (M.S., PharmD, Ph.D., or M.D.) in life or health science

• RAC certification

About the Company

• Syner-G is a strategic biopharma product development and delivery partner recognized as a BioSpace Best Place to Work in 2026.