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

We are looking for a Clinical Project Manager with excellent English communication for clinical trial management. General Statement: Responsible for the overall operational planning and activities for the implementation and conduct of clinical studies 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. Plan, execute, oversight, and manage the clinical trials 2. Plan budget and control cost of the clinical trials 3. Manage and oversight vendors to ensure the achievement of various clinical trial milestones 4. Timely report clinical trial progress to internal project team and stakeholders 5. Proactively identify challenges or quality issues in the execution of clinical trials 6. Develop good relationship and maintain frequent contact with investigators and site staff 7. Conduct co-monitoring visits at clinical sites as necessary 8. Perform clinical data review of tables, figures and listings 9. Assist in reviewing AEs/SAEs and annual safety reports 10. Assist in reviewing Clinical Study Report 11. Provide clinical trial expertise in support of other departments and line functions 12. Assist in the development and maintenance of work instructions for clinical operations department

Lin BioScience, Inc. is seeking an outstanding research associate to join our R&D team. The full-time position will assist the research and development as well as administrative works. Under the supervision of Research Scientist, the research associate will be responsible for: 1. Using a variety of biological and chemical analytical techniques to conduct assay. 2. Summarize scientific data for internal review. 3. Collect and compile regulatory information and guidelines relevant to drug development. 4. Responsible for administrative tasks and paperwork in the laboratory and other assignments as delegated by supervisors. This position will be based in the lab located in Nangang Software Park, Taipei. ※本公司將評估該職務內容及個人學經歷從優核定給薪。

仁新醫藥股份有限公司正在尋找一位優秀的研發專員或是科學家(學士、碩士、或是博士級科學家)加入我們的研發團隊。此職缺將專注於新藥開發所需要的生化實驗以及細胞實驗等技術。此職缺需要總結實驗數據並能夠撰寫科學報告來解釋數據。此職位任職於我們在台北南港軟體園區的實驗室。 必要資格  化學、生物學、細胞生物學或相關學科的學士或碩士或博士學位  高度自我激勵和目標導向  具備靈活性的團隊合作夥伴，熱衷於溝通與內部及外部夥伴合作。  注意細節並有獨立設計實驗能力  在實驗室方面具有豐富經驗  在計劃、執行和分析實驗方面表現出卓越能力，英文能力能夠撰寫技術報告和內外溝通  能夠具有解決問題能力並改進實驗方法 ※本公司將評估該職務內容及個人學經歷從優核定給薪。

Required qualifications: • Manage and outsource contract manufacturing organizations on drug substance manufacturing. Experienced in resolving problems encountered during chemical synthesis. Experienced in providing tactics to support organic synthesis and analytical characterization. • Support oral dosage and liquid dosage forms of small molecule drug product manufacturing by working with CMOs (Contract Manufacturing Organizations) • Experienced in HPLC, LC-MS, NMR, and chemical/compound synthesis is preferred. • Prepare and present summaries of work for department and project meetings • Manage external collaborators • Author grant applications and submissions •Facilitate communication between internal project team and external CMOs to address issues, milestone achievement and project progress.

Required qualifications: •PhD or MS in biology, cell biology, or related discipline in biological science. •Highly self-motivated and goal-oriented •Flexible team player excited to collaborate with internal and external partners •Attention to detail and careful record-keeping •High level of experience with cell culture and molecular biology-based assays •Demonstrated excellence in planning, executing and analyzing experiments, able to write technical reports and protocols •Able to troubleshoot and develop experimental improvements •experience in drag industry is preferred. •Proven ability to work independently, think strategically and self-mitirated.

General Statement: The (Senior) Clinical Research Associate is accountable for managing and overseeing the execution of complex Phase I-IV clinical trial sites. This position requires close collaboration with investigational sites, the CRO and internal teams to ensure trials are conducted with exceptional quality, strict compliance, and operational efficiency. Additionally, select project management responsibilities may be assigned to support the (Sr) CRA's progression towards a Clinical Project Manager role over time. Primary Duties and Responsibilities, including mental requirements of position: • Responsible for oversight of assigned investigator sites, supporting successful execution throughout all phases of the clinical trial lifecycle. • Organizes and conducts various types of site visits (PSV, SIV, IMV, COV) in alignment with the monitoring plan. • Builds and maintains strong working relationships with investigators and site staff to help achieve key clinical milestones. • Coordinates timely delivery, appropriate storage, and accountability of clinical supplies, and assists with drug safety matters as needed. • Demonstrates working knowledge of ICH/GCP guidelines and applicable local regulatory requirements. • Brings strong leadership, mentoring, and organizational abilities. • Shows solid analytical thinking and effective problem-solving skills. • Displays a willingness to learn and take on basic project management responsibilities, where appropriate.