Consultant I, Medical Writing

About the role

T he MWS Consultant I plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables that align with client expectations and regulatory standards. This role is responsible for leading document development efforts, coordinating regulatory projects, and collaborating with cross‑functional teams to meet diverse client needs across varying stages of development.

What you'll do

• (This list is not exhaustive and may be supplemented or changed as necessary.)
• Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials
• Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications)
• Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines
• Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands

What you need

• 3–6 yrs of experience
• Writing
• Regulatory affairs
• Clinical research
• MS Project
• PowerPoint
• Quality control
• M.Pharm or PhD

Good to have

• SOP writing