| Resume alert | Resumes 11 - 20 of 542 |
Business Development Inside Sales
Havertown, PA, 19083
... SOPs Streamlined continuous improvement processes and program management which generated improved KPIs, financial metrics Met FDA deadlines for Alkermes safety updates by working closely with internal Medical Legal Review process Team Lead Vaccine ... - Mar 26
... SOPs Streamlined continuous improvement processes and program management which generated improved KPIs, financial metrics Met FDA deadlines for Alkermes safety updates by working closely with internal Medical Legal Review process Team Lead Vaccine ... - Mar 26
Analytical Development Molecular Biology
Lansdale, PA, 19446
... • Conducted assessment of the IND/BLA filings in compliance with FDA regulatory and pharmacopeial guidelines. • Supervised and trained technical staff. Shin-Yi Du, Ph. D., Resume – Page 1/2 P A G Postdoctoral Fellow (2019 – 2021) Northwell Health - ... - Mar 24
... • Conducted assessment of the IND/BLA filings in compliance with FDA regulatory and pharmacopeial guidelines. • Supervised and trained technical staff. Shin-Yi Du, Ph. D., Resume – Page 1/2 P A G Postdoctoral Fellow (2019 – 2021) Northwell Health - ... - Mar 24
Pharmaceutical SME RE: PV., Clinical research, Medical monitoring
Schwenksville, PA
... Jul-2012 – Jul-2014 Adverse Experience Reporting Coordinator III (contract position) ·Determines, on the basis of SOP’s and FDA regulations, the prompt or periodic classification of each adverse experience contained in the reports received for Merck ... - Mar 09
... Jul-2012 – Jul-2014 Adverse Experience Reporting Coordinator III (contract position) ·Determines, on the basis of SOP’s and FDA regulations, the prompt or periodic classification of each adverse experience contained in the reports received for Merck ... - Mar 09
R D Analytical Chemist
Malvern, PA
... • Reviewed lab personnel notebooks for compliance with FDA regulations and internal SOPs. • Recipient of an Above & Beyond Award. EDUCATION MS, Biochemistry, East China University of Science and Technology, Shanghai, China Thesis: Chemical ... - Mar 05
... • Reviewed lab personnel notebooks for compliance with FDA regulations and internal SOPs. • Recipient of an Above & Beyond Award. EDUCATION MS, Biochemistry, East China University of Science and Technology, Shanghai, China Thesis: Chemical ... - Mar 05
Design Engineer Product Development
West Chester, PA
... Experience within a regulated industry (medical devices desirable, along with knowledge of Product Lifecycle Management, FDA Quality System Regulations and ISO 13485) Responsible for tracking of CR/CN in Windchill with Approval from stakeholders ... - Mar 04
... Experience within a regulated industry (medical devices desirable, along with knowledge of Product Lifecycle Management, FDA Quality System Regulations and ISO 13485) Responsible for tracking of CR/CN in Windchill with Approval from stakeholders ... - Mar 04
Business Analyst Quality
Chester Springs, PA
... ●Created all required validation documentation processes as per the guidelines of the FDA. ●Involved in the process of document binder creation which is helpful for the FDA Audit. ●Involved in creating an FDS document for the ARCOS Quarterly report ... - Mar 01
... ●Created all required validation documentation processes as per the guidelines of the FDA. ●Involved in the process of document binder creation which is helpful for the FDA Audit. ●Involved in creating an FDS document for the ARCOS Quarterly report ... - Mar 01
Quality Assurance Data Management
Philadelphia, PA
... provided Quality oversight of internal and external clinical trial activities, related records, and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs and all other applicable regulations and assisted with other tasks ... - Feb 26
... provided Quality oversight of internal and external clinical trial activities, related records, and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs and all other applicable regulations and assisted with other tasks ... - Feb 26
Business Development Technical Support
Havertown, PA
... ability to talk with individuals at all levels • Very knowledgeable with CRO, Clinical trial processes, HIPAA and other myriad FDA regulations and compliances Professional Experience Diagnostic Solutions Laboratory 2013-2022 Director, New Business ... - Feb 22
... ability to talk with individuals at all levels • Very knowledgeable with CRO, Clinical trial processes, HIPAA and other myriad FDA regulations and compliances Professional Experience Diagnostic Solutions Laboratory 2013-2022 Director, New Business ... - Feb 22
Analytical, great communicator, strategic, planning & organized
Pennsauken, NJ
... lung, and gastric cancers across 15 sites in the United States from start-up activities including feasibility, final protocol, FDA follow-up, study and site contracts and budgets, master ICF development and approval, oversight of site ICF ... - Feb 18
... lung, and gastric cancers across 15 sites in the United States from start-up activities including feasibility, final protocol, FDA follow-up, study and site contracts and budgets, master ICF development and approval, oversight of site ICF ... - Feb 18
Business Development Revenue Growth
Philadelphia, PA
... Key Achievements: • Secured FDA approval for five items within a 24-month timeframe. • Introduced high-speed, needle-free injection systems at US military bases. • Positioned the company as a frontrunner in global health endeavors targeting ... - Feb 11
... Key Achievements: • Secured FDA approval for five items within a 24-month timeframe. • Introduced high-speed, needle-free injection systems at US military bases. • Positioned the company as a frontrunner in global health endeavors targeting ... - Feb 11