Job Description
Pharmaceutical and biotech company seeks CMC Technical Writer to develop and review technical documents, author regulatory documents, and collaborate with cross-functional teams. Company Description: Innovative pharmaceutical and biotech organisation focused on health and nutrition, developing and marketing products that address and support nutritional deficiencies in patients. Job Summary: Join our team as a CMC Technical Writer and play a key part in shaping the success and regulatory approval of innovative drug products. Key Responsibilities: • Write and review technical documents (development reports, protocols, study reports) • Author and compile regulatory documents (CMC sections) • Assist in developing and updating regulatory filings, including master files, technical files for medical devices, and CTDs for drug approvals • Establish and maintain a document management system • Collaborate with cross-functional, international teams for input and feedback Requirements: • Ph D or Master's in science (Chemical Engineering, Chemistry, Bio-Chemistry, Pharmacy, or related field) • 3+ years of experience in GMP manufacturing or CMC writing • Knowledge of CMC processes, including drug substance/product manufacturing, stability, analytical and formulation development • Ability to convert technical information into regulatory-compliant documentation • Strong communication, planning, and organizational skills • Ability to manage multiple tasks independently in a fast-paced environment Benefits: • Significant career growth and opportunities