- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director, Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters ... the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible… more
- Merck & Co. (North Wales, PA)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Evaluating pre-clinical and translational work for… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be Responsible… more
- Integrated Resources, Inc (West Point, PA)
- …Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs , Biostatistics, Outcomes Research, and Operations to ensure ... validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.… more
- Merck & Co. (North Wales, PA)
- … regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges ... Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, Medical Operations, Innovation… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …new ways to solve problems. Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and ... of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation ~… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …new ways to solve problems.Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and ... of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementationExcellent… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …new ways to solve problems. Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and ... of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation… more
- Merck & Co. (North Wales, PA)
- …complianceAdvertising and promotionProduct labelingClinical research activitiesCommercial and Medical Affairs policies and practicesPolicy initiatives in support of ... business and research activitiesRelated liability and regulatory issues Position Qualifications: Education Minimum Requirement: Graduate of an accredited US law… more
