- Duquesne Light Company (Pittsburgh, PA)
- …including financial analysis, market research, and risk assessments, specific to the regulatory and operational frameworks of the utility industry. + Negotiate deal ... transition and value realization and alignment with company goals and regulatory requirements. 1. **Strategic Partnerships:** + Develop and nurture strategic… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the ... assigned programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific leadership to cross-functional study… more
- University of Pennsylvania (Philadelphia, PA)
- …submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Job Description This position is ... processing of biological specimens and manage study data and regulatory files per GCP. + Work with Regulatory... regulatory files per GCP. + Work with Regulatory Affairs Specialist to prepare for audits, review … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Global Vice President QARA Compliance provides assurance and manages all aspects of Regulatory Compliance. The focus will be over the implementation of the Global ... Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is responsible for… more
- Raymond James Financial, Inc. (Harrisburg, PA)
- …future._** We are seeking a detail-oriented professional with hands-on experience in regulatory reporting, specifically with **CAT** and **CAIS** , to support our ... the following corporate home office locations: Memphis, TN or Southfield, MI. The Regulatory Operations Analyst ( _CAT/CAIS Reporting Analyst_ ) plays a key role in… more
- J&J Family of Companies (Malvern, PA)
- …with all J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines, including FDA, EMEA and regulatory bodies ... ongoing laboratory investigations. Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in… more
- Parexel (Harrisburg, PA)
- …are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we ... on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a… more
- Merck (West Point, PA)
- …on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project ... I), ensuring robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and quality frameworks applicable… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, ... Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled… more
- Kelly Services (Horsham, PA)
- …teams as needed and ensure completeness and consistency of complaint and regulatory reporting documentation. + The position collaborates with business partners to ... fields to Medical Safety to support on-time filing of initial and supplemental regulatory reports. + Evaluate reportable regulatory decisions to ensure accuracy… more