Senior Technical Writer, CMC

December 14

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Telxius

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Towers and Cable

201 - 500 employees

📡 Telecommunications

🚗 Transport

🔐 Security

💰 Venture Round on 2017-09

Description

• Supporting the international roll-out of prostate cancer imaging agent. • Leading the technical (CMC) regulatory writing to accelerate development of diagnostic and therapeutic assets. • Leading the preparation of quality/CMC sections of regulatory module 3 dossier. • Project managing contract technical writers. • Compiling, writing, and editing high-quality module 3 documents. • Developing and updating SOPs, processes, templates, style guides, and manuals. • Ensuring compliance with regulatory guidelines and industry best practices. • Managing multiple regulatory technical writing projects • Coordinating with cross-functional teams to resolve issues. • Providing medical writing expertise and mentoring junior writers.

Requirements

• Bachelor’s degree in a scientific or related field required; MS or PhD preferred. • 8+ years’ overall experience in technical/CMC writing, 5+ 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