Mingyao (Peter) Z.

Manager, Clinical Affairs and Medical Writing @ Stryker

About

• A seasoned professional with 16 years of experience in medical device clinical studies (pre-market and post-market), leading complex project management initiatives across Greater China within multinational corporations. PMP Certified. • Successfully delivered key project milestones, including obtaining NMPA pre-market approvals, fulfilling conditional approval requirements, and executing post-market surveillance. Study outcomes have been published in over 20 manuscripts in peer-reviewed medical journals, translating data into clinical evidence.• Recognized by project sponsors, clinical leaders, and collaborators for strong leadership in managing clinical trials, resolving complex challenges, adapting to regulatory changes, and consistently delivering results on schedule.Therapy: Cardiovascular (Heart, Coronary), Surgical (Lung, Esophagus, Neurovascular, Surgery)Strengths: Project Management, Medical Affairs & Scientific Communication, Regulatory Writing, Data Review & Analysis & Visualization, Translation, etc.Certifications: PMP, Medical Device GCP, Drug GCP, Translator (CATTI, Chinese/English), Statistics (SPSS, intermediate level), ISO14155:2020, etc. Software Skills: MS Project, Power BI, PASS, SPSS, Smartsheet

Country

China

City

Shanghai

Industry

Hospital & Health Care

Skill

Clinical Evaluation, Regulatory Insights, ISO14155, EU MDR, Program Management, Human Genetics, Clinical and Regulatory Strategy, Medical Affairs, Scientific Communications, Clinical Evaluation Report, Clinical Research, Project Management, Registration strategies, Clinical Trials, Medical Devices, Regulatory Affairs, GCP, CRO, Project management, 临床试验

Experience

Manager, Clinical Affairs and Medical Writing

Stryker

2024-1 - Present · 2 yrs 9 mos

Shanghai, China

1) Lead and empower Clinical Affairs and Medical Writing teams 2) Drive pre-market and post-market studies towards clinical excellence and on-time delivery 3) Develop evidence strategies and share regulatory insights

Senior Project Manager

Premier Research

2023-3 - 2023-12 · 10 mos

中国上海市

1) Lead clinical study efforts from Overseas to APAC and vice versa - Strategy & delivery - Program management - Client relationship 2) Support bid-defense meetings and other efforts to win awards 3) Represent the company at conferences or seminars, eg. Suzhou MedPark tour, 2023 Shenzhen CMEF (keynote speaker in international device regulations), etc.

Clinical Project Manager

Edwards Lifesciences

2021-11 - 2023-3 · 1 yr 5 mos

Shanghai, China

1) Project management of pre-market studies & post-market studies 2) Clinical & Registration strategies 3) HGRAC (human genetics) regulation and SME 4) Mentor junior colleagues incl. CRAs to deliver growth and empowerment 5) Drive to publish the 1st manuscript in Chinese population based on heart valve pre-market study 6) Lead CMDE and HGRAC consultation to minimize submission risk in advance 7) Lead and drive the collaborations with Shanghai FDA and industry associations for post-market surveillance 8) Attend NPD committee of CCV to support new product development activities with strategic insights

Principal Clinical Research Specialist

Medtronic

2014-7 - 2021-11 · 7 yrs 5 mos

Shanghai, China

1) Clinical Research - project management & operations, study design, HGRAC, draft synopsis, review proposals, drive processes, submission & filing review, panel meeting, etc. 2) Clinical Evaluation Report - clinical review & approval 3) Medical Affairs / Scientific Communications - project management, evidence summaries, value dossiers, medical writing, publication support, etc. 4) Investigator sponsored studies - review & approve proposal, evidence strategy, project management, evidence dissemination etc. (~ 20 manuscripts published in SCI medical journals) 5) Clinical evidence strategies 6) Manage unexpected situations, problem solving and risk mitigations 7) Mentor junior colleagues and make sure projects delivered with high compliance and preferred quality 8) Drive to publish 20+ manuscripts based on clinical study results

Senior Clinical Research Associate

PerkinElmer

2012-4 - 2014-6 · 2 yrs 3 mos

Shanghai, China

Clinical Research - project management & operations 1) Managed medical device/IVD/SaMD pre-market studies in prenatal/neonatal screening, and epidemic disease field 2) Completed 8 clinical studies successfully, nearly all received NMPA pre-market approvals 3) Managed a supplementary study of the IVD Kit according to the DL in a short period of time 4) Successfully managed the first SaMD clinical study (Pregnancy Risk Calculation Software) in Greater China and obtained regulatory approval to have avoided the business risk