- Cytel (Harrisburg, PA)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... coding of medical terms using standardized dictionaries (eg, MedDRA, WHO Drug ). This individual brings advanced knowledge of medical terminology, clinical trial… more
- Pfizer (Collegeville, PA)
- …experience OR PhD with 1+ years of experience. + Relevant work experience in drug development across various phases of drug development. + Relevant work ... experience in a pharmaceutical or biotech environment. + Understanding of FDA regulations, Good Clinical Practice (GCP), and ICH guidelines; Experience working… more
- Charles River Laboratories (Wayne, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more
- Charles River Laboratories (Horsham, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more
- J&J Family of Companies (Malvern, PA)
- …teams. She/He will learn from and contribute to industry-leading drug discovery/development programs that has brought numerous quality therapeutics to ... + Author or coordinate appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address product characterization related inquiries. + Effectively… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- University of Pennsylvania (Philadelphia, PA)
- …Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, initial ... responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute to Informed Consent… more
- Parexel (Harrisburg, PA)
- …experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- Charles River Laboratories (Horsham, PA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and… more
- Charles River Laboratories (Collegeville, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more