Angela Li Email & Phone Number

• Created penetration strategy for a start-up to explore dental product market opportunities by performing technology assessment, gathering voice of customers, prioritizing market segments and analyzing healthcare insurance reimbursement process.• Identified market opportunities for five innovative medical products designed by doctors. Made recommendations to potential investors whether or not to proceed with development based on technical and financial evaluations, market size analysis, assessment of intellectual property and regulatory challenges.

• Monitored competitive landscape and mapped out market dynamics. Formulated short/long term marketing strategy and implemented marketing campaign to differentiate company’s product against competition. • Built product claim which align portfolio with patient care therapy and supported by clinical research evidence. Provided consumer insight, new product needs and development recommendation to international marketing team.• Led cross-functional team to launch new products. Responsible for initiating launch strategy and supporting execution. Created collateral, sale tools, educational materials and training programs to maximize product knowledge of sales team, distributors and customers. • Established relationship with key opinion leader (KOL) and built up KOL network to achieve growth goal. Managed relationship with Chinese Society of Nephrology as well as sponsorship of conference and event to engage physician customers. Attended trade show and exhibit.

• Managed three Phase Ⅲ clinical trial sites. Ensured clinical study was conducted per established policies, standard operation procedures (SOPs), regulations, and Good Clinical Practice (GCP). • Assisted investigator and site selection. Managed investigator contract, clinical trial budget and financial reconciliation process.• Conducted site initiation visits, monitoring visits and follow-ups to identify problems and issue. Advised and trained site personnel on protocol and regulatory requirements. Arranged site meetings and multi-center investigator meetings. • Reviewed on-site files and records, clinical report forms, and source documents for completeness, accuracy, consistency, and compliance. Identified discrepancies and initiated corrective action. Managed Trial Master File and contributed to the writing of Clinical Study Report.

• Reviewed, ranked, verified, processed and documented individual case safety reports (ICSRs) for AE and serious adverse event (SAE) from clinical studies and post-marketing activities of Pfizer’s pharmaceutical products and devices launched in U.S. to ensure all deadlines were met and compliance with global safety regulations, SOPs and relevant FDA/ICH guidelines.• Coded AE/SAE according to MedDRA. Wrote and edited case narrative based on electronic data capture (EDC). Identified clinically significant information missing from initial reports. Distinguished cases with particular complexities and/or specific issues including product complaint information and escalated appropriately. Alerted with potential safety signals.• Reviewed case criteria to determine workflow including generating and requesting follow-up letters. Executed SAE reconciliation in Oracle Pharmacovigilance (PV) database - Argus. Assisted in aggregate and periodic reporting including development safety update reports (DSURs) and Periodic Safety Update Reports (PSURs).

• Investigated product benefits and safety with sensory evaluation (Home Usage Test), clinical evaluation (skin and eye irritation) and performance testing. Designed, coordinated and executed clinical studies/evaluation projects, responsible for protocol development, oversight of protocol conduct and budget/timeline management with CROs. • Collected, analyzed clinical trial data with statistical analysis software and prepared summary report. Provided clinical research supported evidence for product claims substantiation. Communicated and interpreted clinical trial result as well as provided technical support to internal/external customers. Interfaced with customers in support of sales efforts and collaborative product development.• Owned category consumer insight, competitive activities, emerging technologies/raw material, and trends to provide innovative ideas into future product development. Continuously identified opportunities for category evolution and developed robust testing programs to substantiate skincare claims. Discovered new compelling approaches to describe technology benefits to consumers.• Prepared formulation for new skincare product. Adjusted formula based on evaluation feedback. Assisted in the planning and execution of scale up manufacturing testing. Collected, organized and reviewed formula and raw material documentation for regulatory compliance.

Master Of Science - Ms, Biochemistry And Molecular Biology

Master Of Business Administration (Mba)