Amanda Xiaoqing Mao, Phd Email & Phone Number

Melbourne, Vic, Au

Lexington, Massachusetts, Us

Coordinate engagement and communication with the development partner in China on clinical trials and CMC.

Fukuoka, Jp

Edanz conducts clinical trials. I oversee multiple international clinical trials for Australian sponsors, ensuring delivery of results within set timelines, budgets and quality standards. Edanz also provides academic editing and publishing services. • Lead the selection of Contract Research Organizations (CROs), central laboratories, biostatistical vendors, and Sponsor Clinical Research Associates (CRAs) by leveraging a broad professional network remotely and in person. • Spearhead project planning, execution, evaluation, and reporting.• Provide project-specific guidance, manage interactions, oversee deliverables with the China teams, and supervise day-to-day operations.• Serve as the main liaison for sponsors and handle client expectations through regular video calls and emails.• Proactively identifies potential operational challenges and collaborates with CROs, other vendors, and colleagues to resolve issues, ensuring timely, within-budget, and high-quality trial completion.• Provide insights into study protocols, case report forms, and informed consent. • Oversee site evaluation, initiation, routine monitoring visits, and close-out visits through CROs and CRAs as direct reports. • Oversee the preparation of statistical analysis plan, statistical analysis report, safety, and clinical study report, including coordinating to resolve any queries.• Lead weekly project meetings with CRO and other vendors in Chinese.• Register and update trial status on www.clinicaltrials.gov.• Manage manuscript writing, submission, and post-submission revisions until publication in peer-reviewed journals.• Empower business presentations for Chinese clients seeking Edanz services and resolve difficult situations during project execution.

Fukuoka, Jp

Clinical trial project management, bilingual Chinese publication writing and editing on pharma and nutrition, literature search, and medical translation

Melbourne, Vic, Au

• Invited as a panel speaker at the Australia China Health Summit 2024, a sold-out event with 95 on-site participants.• Invited as a panel speaker at the Australia-China MedTech Investment Forum 2023, drawing an audience of over 100 both in person and online.

Melbourne, Victoria, Au

Acurit provides bilingual Chinese consulting services for the life sciences industry. • Find, secure, and manage bilingual Chinese projects in pharmaceuticals and nutrition including clinical trials and manuscript development. • Perform bilingual Chinese medical affairs writing and consulting. • Oversee medical translation between English and Chinese. • Perform literature searches and reviews in English and Chinese on pharmaceuticals, nutrition and medical devices. • Prepare clinical evaluation reports for medical device registration with China's National Medical Products Administration.

Adelaide, South Australia, Au

• Conducted Chinese English medical writing. Carried out literature search and literature critical review for a clinical trial protocol design and grant writing. This was completed with high recognition from the discipline head, program head and the collaborating professor.• Developed a research paper building up from the above protocol/grant.

Eastwood, South Australia, Au

Regulatory writing and phase I clinical study report (CSR) writing to file with FDA on a Central Nervous System new drug.

New York, New York, Us

As Medical Compliance Lead at Pfizer Consumer Healthcare for China and Hong Kong, reviewed and ensured commercial activities engaging HCPs were compliant with the Sunshine Act.

New York, New York, Us

Products in scope: nutritional supplements, respiratory, pain management, dermatology, personal care. Responsible for medical affairs strategy and activities for the Asia Pacific region with China and Hong Kong the biggest focus. Chinese English medical writing is an overarching skill. As Senior Medical Affairs Manager for the Asia Pacific region with Pfizer Consumer Healthcare (PCH), a global leader in the sale and marketing of non-prescription pharmaceuticals and personal care products, led the formulation and implementation of the corporation's Medical Affairs strategy for the region, with a special focus on China and Hong Kong. This entailed educating internal and external stakeholders on scientific topics, carving pathways and reviewing patient outcomes; appraising different categories of stakeholders - including ministries of health, pharmaceutical products distributors and healthcare providers on the value and efficacy of different product lines; planning and generating evidence and data on the efficacy of products under trial and preparing reports to guide the company's product development and marketing.Led the cross-functional team of Medical Affairs, Regulatory and Marketing on the first internal corporate-level Medical Quality Assurance (MQA) audit for PCH Hong Kong. Co-authored and coordinated response and remediation document to the audit report. There were no critical findings in the audit outcome, which was a positive sign for pharmacovigilance processes and systems.Conducted medical due diligence for product licensing and acquisition to support business development, including evaluation of dosage, efficacy and safety. One of the core brands in Pfizer Consumer Healthcare was entirely through acquisition, with a single year investment of US$ 7.4 million.

New York, New York, Us

Lead medical affairs strategy and activities for the Asia Pacific region at Pfizer Consumer Healthcare. Main countries and regions include China, Hong Kong, Singapore and Australia.

Quarry Bay, Hong Kong, Hk

Biostime is a premium paediatric nutrition and baby care products provider in China. In 2015, Biostime acquired Swisse Wellness Group in Australia, further expanding its product scope in nutritional supplements.• Directed and managed two international nutraceutical clinical trials, covering scientific and managerial aspects, for the cross-organisational and multinational teams to achieve on-time and on-budget delivery.

Doctor Of Philosophy - Phd, Biochemistry, Molecular Nutrition

5Th Iea International Course On Epidemiological Methods

Bachelor Of Science (Bsc), Pharmaceutical Analysis