Onphimon Akkharawasu
Scientist @Merck
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WORK HISTORY
Scientist @Merck
Designed and coordinated in vivo safety study protocols at Contract Research Organizations (CROs) for global and local registration and approval of veterinary pharmaceuticals as well as product development under GLP regulations and SOP guidelines• Monitored a conduct of studies at CROs including pre-study discussions, meetings, on-site visits, and protocol review/ training to ensure CRO compliance with the study protocol and relevant FDA regulations and guidelines• Participated in identifying potential CROs to conduct a study and assisted in the preparation of study contracts and agreements• Collaborated and maintained positive relationships with both internal and external partners and other functional areas to drive results• Successfully obtained regulatory approval by ensuring all data generated both in-house and at CROs followed regulatory regulations and study protocols by thorough reviewing, monitoring raw data, study documentations and reports, and attending FDA/CVM meetings to keep up-to-date and well-informed about changes or new requirements• Led in review and generation of raw data package (XML/ README files) and all relevant documents and reports to ensure up-to-date and accurate submission of data and documents to Regulatory Agencies on Veeva Vault RIM• Maintained project timelines and communicated regularly with Study Lead in tracking progress and all study-related activities• Regularly stayed up to date on new guidelines or regulations by actively attending meetings and conferences
EDUCATION
Rutgers University
Bachelor’s Degree, Chemistry and Chemical Biology
SKILLS
ABOUT ONPHIMON AKKHARAWASU
Highly motivated scientist with the aspiration to learn and develop new skills. Often takes initiative and takes on additional responsibilities to ensure that all projects meet tight deadlines.
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