- 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
- Doctorate degree OR
- Master's degree with 4–6 years of directly related experience OR
- Bachelor's degree with 6–8 years of directly related experience OR
- Diploma with 10–12 years of directly related experience
- 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
- 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
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Global Regulatory Writing Manager - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
Description
Roles & Responsibilities
Basic Qualifications
Preferred Functional Skills
Soft Skills
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