Manager, Medical Writing (REMOTE)

Role Summary

The Medical Writing Manager in Global Regulatory Medical Writing is responsible for writing and editing clinical regulatory documents, providing oversight and guidance, and managing resources for medical writing support in clinical research documentation used in drug development and product registration.

Responsibilities

• Writes and edits clinical regulatory documents (e.g., study reports, protocols, briefing books, investigator’s brochures, health authority responses, Module 2.5 and 2.7.x).
• Compiles, analyzes, and summarizes data.
• Proofreads, edits, formats documents, and resolves comments.
• Ensures regulatory compliance and scientific clarity.
• May contribute to SOPs and templates.
• May train/support writers or vendors.

Qualifications

• Required: 5+ years of relevant experience, Lead author experience in: Protocols/protocol amendments, Clinical study reports, Investigator’s brochures, Clinical summary documents (Modules 2.5, 2.7.1–2.7.4)
• Preferred: 6+ years with an advanced degree, Lead author experience in at least 4 of the 6 document categories listed above

Skills

• Mastery of Microsoft Word
• Familiarity with Veeva Vault and other electronic formats
• Solid writing/editing skills
• Understanding of global regulatory guidelines and AMA style
• Familiarity with drug development, therapeutic areas, and statistical concepts
• Excellent written and spoken English
• Strong interpersonal, critical thinking, and administrative skills
• Ability to lead document development processes and meetings
• Effective communication with cross-functional teams and regulatory authorities
• Project management and timeline tracking
• Problem-solving and escalation
• Contribution to process improvement and budget planning

Education

• Required: Bachelor's in life sciences or related field
• Preferred: Master's, MD, PhD, PharmD

Additional Requirements

• Location: US-Based Remote (US Eastern time zone preferred)
• Travel: Up to 10% Domestic