Technical Writer - CMC

December 13

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Telxius

WebsiteLinkedInAll Job Openings

Towers and Cable

201 - 500 employees

📡 Telecommunications

🚗 Transport

🔐 Security

💰 Venture Round on 2017-09

Description

• Support the international roll-out of our approved prostate cancer imaging agent. • Advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. • Lead the preparation of the quality/CMC sections of the regulatory module 3 dossier and associated information in agency briefing books using internal manufacturing and quality source documentation.

Requirements

• Bachelor’s degree in a scientific or related field required; MS or PhD preferred. • 5+ years’ overall experience in technical/CMC writing, 2+ years within Regulatory CMC required • Experience overseeing and mentoring contractors and junior team members strongly preferred • Strong understanding of drug development, drug substance and drug product manufacturing, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. • Experience and proficiency with document templates, document toolbars and proper version control. • Strong project management skills. Organized and self-motivated. Strong attention to detail.

Benefits

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development