- Penn Medicine (Philadelphia, PA)
- …(The Joint Commission), OSHA (Occupational Safety and health Act), NRC (Nuclear Regulatory Commission), DEA ( Drug Enforcement Agency), DOT (Dept. of ... teaching functions with residents/fellows, Medical Laboratory Science and other students. ** Regulatory Compliance** : + Works with the Division's Quality Assurance… more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Honeywell (Pottsville, PA)
- …maintain professionalism in the face of conflict. + Working knowledge of the Regulatory environment and submission guidelines for new drug product registration ... process including ICH stability guidelines. Familiarity with FDA , EMEA & Japanese Regulatory requirements relating...guidelines. Familiarity with FDA , EMEA & Japanese Regulatory requirements relating to package design and selection for… more
- Sumitomo Pharma (Harrisburg, PA)
- …Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health Hazard ... Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product...Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience… more
- Norstella (Harrisburg, PA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… 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
- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other ... production of submission-ready clinical research documentation in support of drug development, product registrations, and product marketing. The Clinical Publisher's… 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
- Cardinal Health (Harrisburg, PA)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- Cytel (Harrisburg, PA)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory… more