Global Regulatory Writing Manager

Roles & Responsibilities

• Author regulatory submission documents such as:
• Clinical Study Reports
• Investigator Brochures
• Responses to Questions
• Protocols and Protocol Amendments
• Informed Consent Forms
• Table of All Studies
• Clinical Overview Addenda
• eCTD Module 2 Clinical Summary Documents
• Briefing Documents
• Pediatric Investigation Plans
• Other regulatory documents as assigned
• Conduct formal review and approval of authored documents, adhering to SOPs
• Manage regulatory writing activities for product submissions under supervision, including new and supplemental drug applications/biologics license applications
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
• Provide functional area input for Global Regulatory Plan and team goals
• Collaborate with contract and freelance writers as needed
• Participate in training and mentoring junior medical writers
• Engage in departmental and cross-departmental initiatives
• Generate document timelines with team input
• Stay updated on relevant professional information and technology

Basic Qualifications

• Doctorate degree OR
• Master's degree with 46 years of directly related experience OR
• Bachelor's degree with 68 years of directly related experience OR
• Diploma with 1012 years of directly related experience

Preferred Functional Skills

• Proficient with Microsoft Word and Office programs
• Strong knowledge of scientific/technical writing and editing
• Thorough understanding of clinical development processes for new compounds
• Ability to understand and follow complex SOPs, guidance documents, and work instructions
• Substantial knowledge of ICH and Good Clinical Practice (GCP) guidelines and requirements

Soft Skills

• Excellent written and oral communication skills with strong attention to detail
• Demonstrated leadership abilities within a team environment involving negotiation, collaboration, and analytical judgment
• Effective time and project management skills
• Self-motivated with drive and perseverance to achieve results