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