仁新醫藥股份有限公司

General Statement: Provide the overall supports for the implementation and conduct of clinical trials in accordance with prevailing laws and ICH GCP within established timelines and budgets Reports to: Chief Operating Officer Primary Duties and Responsibilities, including mental requirements of position: 1. Work closely with Clinical Project Manager 2. Understand clinical trial protocol and support the communications with clinical sites and vendors on the study conduct 3. Support study budget planning and communicate with the internal stakeholders 4. Manage the contract, purchase order process, and process the invoices of investigator sites and vendors 5. Update and maintain project tracking systems and schedules 6. Coordinate import and export for clinical trial materials 7. Manage and maintain clinical trial related documents 8. Coordinate meetings, prepare meeting slides and meeting minutes

We are looking for a CMC scientist/manager with excellent English communication for CMC management. General Statement: Lead the planning, evaluation, and execution of CMC strategy for all pipeline products. The position will be responsible for management of all CMC activities including but not limited to evaluation and selection of Drug Substance and Drug Product contract manufacturers, technical lead and oversight of contract manufacturing and contribution to regulatory submissions and interactions with regulatory authorities. The individual will report to VP, Pharmaceutical Sciences. Job Responsibilities: • Lead cross-functional planning of CMC strategies for early phase and late phase pipelines to ensure drug development timeline and achieve business targeted outcomes • Sourcing, evaluation/performing risk assessment and selection of Drug Substance and Drug Product contract manufacturers • Provide strong technical leadership and oversight of all CMC projects inclusive but not limited to technical transfer, formulation development, process development, analytical method development and validation at contract manufacturers to ensure cGMP compliance and regulatory requirements • Lead and oversight of manufacturing process optimization and scale-up, manufacturing of registration batches and process validation moving forward to commercialization • Ensure establishment of appropriate specifications for Drug Substance, Drug Product, intermediates, excipients and etc. • Review protocols, development reports, batch records, standard operating procedures, and other technical reports • Author and review relevant CMC sections of IND, IMPD and NDA submissions and ensure regulatory compliance