⚫ Critically review and revise clinical trial protocols
⚫ Serve as primary communicator with Clinical Trial CRO providers and regulatory authorities.
⚫ Identify and communicate with local and international KOLs in therapeutic indications related to Formosa Pharmaceuticals’ programs
⚫ Identify and engage with consultants and CROs for services related to company programs
⚫ Generate and make presentations on behalf of Formosa Pharmaceuticals at external meetings and conferences
⚫ Foster collaborative relationships with employees both within and outside the company
● Evaluate, recommend, plan, implement, and maintain strong practice
standards for company R&D and GMP activities
● Provide guidance, review, and approve R&D and manufacturing protocols,
batch records, and QC SOPs
● Review and approve protocols, reports, and deviations as it relates to
validation and manufacturing activities.
● Plan, schedule, conduct, and report external audits and inspections
globally or domestically as needed.
● Establish Quality Agreements with CRO and CMO providers.
● Communicate Quality and audit findings with appropriate personnel;
establish and implement action plans (CAPA), Change Control, and
Deviation reports when required