Weiwei Gao
Senior Medical Writer @ Quintiles
About
• Over 3 years experience as a medical writer within a pharmaceutical environment, 6 years experience in academic research, and 6 years experience in hospital pharmacy. • Issued medical writing deliverables for regional or China only clinical trials on time and with good quality, including 8 full protocols, medium to substantial protocol amendments for 5 different clinical trials, 14 master ICFs, 6 CSRs, and 1 IB in 3 years. • Therapeutic areas of experience include: hepatitis,non-small-cell carcinoma, thyroid cancer, solid tumor, hepatocellular carcinoma, colorectal cancer, diabetes mellitus, alzheimer's disease, myocardial infarction, gastroesophageal reflux disease, pneumonia, herpes zoster associated pain, and controlled ovarian stimulation for ART. • One year experience in medical device technical writing (stent for coronary revascularization)
China
Shanghai
Pharmaceuticals
Medical Writing, Clinical Trials, CRO, Clinical Research, Oncology Clinical Research, GCP
Experience

Senior Medical Writer
Quintiles
Shanghai City, China
• Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience. • Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognized as appropriate. May review ballpark budgets and routine costings, with management support as needed. • Review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development. • Present on standard Medical Writing processes at full-service bid defense meetings by telephone or in person. May input into and deliver presentations on Medical Writing to other Quintiles groups. • Act as Project Manager for a small stand-alone Medical Writing project (e.g. protocol or CSR). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.

Senior Pharmacologist
HD Biosciences (China) Co., Ltd.
Shanghai City, China
• Project management Recruit and manage R&D project team of more than three scientists, report to senior supervisor, facilitate internal and external communication, perform quality control check on project outputs and manage the project budget. • Study Design It includes work proposal and improvement; data analysis and interpretation. • Making deliverables Prepares pharmacology part for IND application dossier, working in accordance with HDBio SOPs and the customer's requirements (more than twenty projects) • Leading/Participating projects 1. Animal model establishments of diabetes & obesity and relevant pharmacodynamic studies. 2. GHS R1a agonist and antagonist identified by in vivo screening. 3. Cosmetic Product Safety Assessment. 4. PK/PD Studies. 5. ADME Studies. • Patent application. GHS R1a agonist identified by in vivo screening.

Pharmacist in charge,lecturer
Tumor Hospital of Xinjiang Autonomous Region
Urumqi, Xinjiang, China
Pharmacist in charge • Clinical pharmacy and clinical pharmacology teaching. • Lead the effort in building both infrastructure and team of total parenteral nutrition room.
Weiwei Gao's Contact Information
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