Medical Writer

Responsibilities

• Author regulatory documents including Clinical Study Reports (CSRs), study protocols, and client submission materials
• Lead development of complex modules such as Module 2 summaries and Briefing Documents
• Manage applications for Orphan Drug, Fast-Track, and Breakthrough Designations
• Apply quality control and submission-readiness processes to ensure high-quality deliverables
• Act as project owner by tracking timelines, adjusting schedules, and coordinating with clients
• Facilitate client interactions, including meetings and feedback discussions
• Collaborate with cross-functional teams to ensure document accuracy and alignment with regulatory standards
• Provide guidance on document management systems and client SOPs

Requirements

• 3+ years of industry experience
• Proficiency in Microsoft Office Suite, Teams, and MS Project
• Familiarity with regulatory document management systems like Veeva Vault
• Experience with regulatory submissions and global regulatory standards
• Strong foundation in medical and regulatory writing
• Knowledge of pharmaceutical and biopharmaceutical environments
• Exceptional project and time management skills

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 that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.