- 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
- Biomat USA, Inc. (Fairless Hills, PA)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a ... all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration… more
- WellSpan Health (York, PA)
- …and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding ... consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of...the safety and welfare of human subjects (ie, DHHS, FDA and IRB research regulations, HIPAA privacy and research… more
- Kedplasma (Pittston, PA)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and...collection center for audits. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. +… more
- Highmark Health (Pittsburgh, PA)
- …responsibilities will include clinical review, assisting in navigating a complex regulatory environment, working with claims data, performing financial analyses, and ... a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization reports, and… more
- Penn Medicine (Yardley, PA)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. + CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- University of Pennsylvania (Philadelphia, PA)
- …meetings and will be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible for accurate data collection ... of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance...limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure compliance with the protocol… more
- Penn Medicine (Philadelphia, PA)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc). ... to emergency/code situations. + CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Pfizer (Collegeville, PA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …leader will drive cross-functional initiatives to enhance product safety, regulatory compliance, and customer experience through advanced data analytics, digital ... with other functions both within and outside of Quality, including Regulatory Affairs, Information Technology, Service, Repair, Manufacturing, Commercial teams and… more