Director/Senior Director, Quality Systems and GxP Compliance
Scholar Rock
Vault
Manager, Medical Writing
Teva Pharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States • Pennsylvania
Visit company websiteSalary
💰 $112,080 - $140,100 per year
Job Level
Mid-LevelSenior
Tech Stack
Vault
About the role
- Write and edit clinical regulatory documents (e.g., study reports, protocols, briefing books, investigator’s brochures, health authority responses, Module 2.5 and 2.7.x).
- Compile, analyze, and summarize clinical data for regulatory documents.
- Proofread, edit, format documents, and resolve comments to ensure regulatory compliance and scientific clarity.
- Provide oversight, guidance, and manage resources for medical writing support in clinical research documentation used in drug development and product registration.
- Contribute to SOPs and templates and may train/support writers or vendors.
- Lead document development processes and meetings and communicate with cross-functional teams and regulatory authorities.
- Track project timelines, manage deliverables, escalate issues, and contribute to process improvement and budget planning.
- Report to Director, Therapy Area Head, Medical Writing.
Requirements
- Education: Bachelor's in life sciences or related field required; Master's, MD, PhD, PharmD preferred.
- Experience: 5+ years of relevant experience required; 6+ years preferred with an advanced degree.
- 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) (required to be lead author for several document types).
- Technical Skills: Mastery of Microsoft Word; familiarity with Veeva Vault and other electronic formats.
- Knowledge: solid writing/editing skills; understanding of global regulatory guidelines and AMA style; familiarity with drug development, therapeutic areas, and statistical concepts.
- Job-Specific Competencies: 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.
- Travel: Up to 10% domestic travel.
- Location/time preference: US-Based Remote (US Eastern time zone preferred).
