- Merck (West Point, PA)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... Bank, Seeds, or Drug Substance lots to ensure conformance to appropriate regulatory requirements. In addition, the Senior Specialist independently proposes… more
- Merck (North Wales, PA)
- …requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement the regulatory ... We are Looking for:** . Minimum: Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs...Work Site/Schedule** . On-site work locations: Upper Gwynedd, PA; Hybrid schedule . Monday-Thursday (Core hours: 9:00 am -… more
- Integra LifeSciences (Princeton, NJ)
- …making headway to help improve outcomes. This position will support the Global Regulatory Affairs team with the requirements for development, maintenance, and ... System (RIMS). This role requires the functional understanding of Regulatory Affairs processes and the ability to...relevant duties as assigned. Additional Details: This role is hybrid between Princeton, NJ and remote Integra LifeSciences is… more
- University of Pennsylvania (Philadelphia, PA)
- …with the current approved study documents, ICH GCP, and with the applicable regulatory requirements. + The Quality Specialist is to confirm documentation ... and much more. Posted Job Title Clinical Research Quality Specialist C (Office of Clinical Research) Job Profile Title... is to ensure the site subject binders and regulatory files are complete and up to date. +… more
- University of Pennsylvania (Philadelphia, PA)
- …contingent upon funding. Job Description Job Responsibilities CRC A + Assist the Regulatory Affairs Specialist in preparing, submitting, and processing ... Penn entities, industry sponsors, and external institution coordinating centers + Assist the Regulatory Affairs Specialist in managing sites for the… more
- Merck (West Point, PA)
- …intellectually curious, join us-and start making your impact today. **Overview:** Global Regulatory Affairs and Clinical Safety - Operations, Processes and ... OPS . Exposure to Senior level positions within the Regulatory Affairs and partner functional areas ....Work Site/Schedule:** . On-site work location: Upper Gwynedd, PA; Hybrid schedule . Monday-Thursday (Core hours: 9:00 am -… more
- University of Pennsylvania (Philadelphia, PA)
- …regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality ... and resources, and much more. Posted Job Title Clinical Research Monitoring Specialist Senior (Cancer Center) Job Profile Title Clinical Research Monitoring … more
- Bausch Health (Bridgewater, NJ)
- …JOB** The Proofreader/SPL Specialist , Labeling is responsible to support US Regulatory Affairs Labeling Leads with labeling activities related to development ... accordance with regulations and company process. **KEY ACTIVITIES/RESPONSIBILITIES** Provide Regulatory support in the development, revision, review, and approval of… more
- University of Pennsylvania (Philadelphia, PA)
- …selection, prioritization of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive ... closely with major internal (PI, CRU Central - Operations, Regulatory , Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug… more
- Kelly Services (Bridgewater, NJ)
- …in company audits, as needed **Requirements:** + Knowledge of medical device industry, regulatory affairs , as well as discipline throughout the product lifecycle ... - Dec 2024, high likelihood of extension into 2025.** ** Hybrid - Can sit in either Rochester, NY or...Ability to understand and apply business drivers outside of Regulatory Affairs . + Strong communication skills; both… more