硕雄 王

 Medical Affairs department setup, recruit, training, and management.  As company medical representative, communication with external partner, regulatory agency, Principal Investigator (PI), etc.  Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including Clinical Operation department, Statistic & Data Management department, Regulatory Affairs, Pre-clinical department, etc.  Medical monitoring for ongoing clinical trials from phase I to phase III  Responsible for medical writing activities, including protocol, clinical study report (CSR), Informed Consent Form (ICF), Investigator`s Brochure (IB), etc.  Oversee and management of third-party studies  Achievements: got 8 IND approvals including 3 FDA approvals. • Pharmacovigilance (PV) management.  PV department set up;  Draft/review PV SOP;  Review Individual Case Safety Report (ICSR), Suspected Unexpected Serious Adverse Reaction (SUSAR), Development Safety Update Report (DUSR), Safety Management Plan (SMP), etc.  PV project management.

• Accountable for the development of China clinical submission communication strategy for TA projects, collaborating with CNPT members and cross-function TA leads. • Accountable for quality and efficiency in project delivery, collaborating with medical writing vendors when needed.

• Medical Affairs department setup (3 managers and 3 specialists), recruit, training, and management; • Draft and update relevant SOPs (Standard Operation Procedures); • Draft and update medical writing related report templates; • Review/Writing clinical trial related documents (protocol, CSR (Clinical Study Report), IB (Investigator's Brochure), clinical summary, CRF (Case Report Form), source document, ICF (Informed Consent Form), etc.); • Prepare medical related documents for NMPA (National Medical Products Administration) IND (Investigational New Drug) or NDA (New Drug Application) submission; • New drug development strategy consulting • Support medical related business Bidding • Discussion with PI (Principal Investigator) on clinical protocol and protocol presentation; • Involved protocol designs or IND submissions of 3 CAR-T projects, 7 category 1.1 new drug, 5 biosimilars, 8 BE studies. TA: oncology, endocrine, rheumatism, cardiovascular, etc. • Pharmacovigilance (PV) management.  Team set up;  Draft/review PV SOP;  Review Individual Case Safety Report (ICSR), Suspected Unexpected Serious Adverse Reaction (SUSAR), Development Safety Update Report (DUSR), Safety Management Plan (SMP), etc.  PV project management.

• Department setup • Draft and update relevant SOPs • Draft and update report templates • Medical Writing/Medical affairs project managements of project assignment, timeline, and cost • Medical review and pharmacovigilence management • Support BD department on bidding • Medical writing：protocol (I-VI) ，CSR (I-VI) ，IB, ICF, manuscript, abstract, Meta-Analysis report, safety report, etc.

• Research, create, edit and coordinate the production of clinical documents, including interim and final clinical study reports, informed consent forms, periodic adverse experience reports, periodic safety update reports, etc. • Serve as primary technical contact with client. • Manage medical writing projects including project plan, timeline, out of scope requests and budget management

• Worked with team including Study Director/Principal Investigator and scientists to deliver accurate and comprehensive bioanalysis, PK, and bioequivelence (BE) reports for contracted studies. • Performed comprehensive QC of the bioanalysis, PK, and BE reports against protocols, data, and format requirements for peer’s work. • Ensured documents were generated in accordance with agreed internal Standard Operation Procedure (SOP) and following relevant regulatory guidelines. • Project coordination and management

• Written and reviewed technical reports including bioanalysis, PK/toxicokinetics (TK), and BE reports in support of Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) studies for various clients. • Prepared clinical trial protocols for BE studies in compliance with Food and Drug Administration (FDA) guidance for Abbreviated New Drug Application (ANDA). • Bioanalysis reports and clinical trial protocols translation from English to Chinese for State Food and Drug Administration (CFDA) submission. • Performed statistical analysis for TK/PK and BE data. • Maintained report templates and updated report template according to regulation guideline or client`s requirements. • Project management including assisting Lab in full director to manage and coordinate projects, communication with internal and external clients.

• Responsible for promoting cell culture products in the east and south-west of China. • Maintained good relationship with key clients. • Distributor development and management in respective territory. • Product promotion, product presentation and technical support.