- Parexel (Harrisburg, PA)
- …while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient ... safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance… 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
- CSL Behring (King Of Prussia, PA)
- …monitor successful reporting and resolve submission failures to minimize impact to regulatory compliance. The Case Submission aspect of the function has a high ... compliance is potentially affected and will require ability to analyze varied regulatory sources and engage readily with diverse stakeholders and Regulatory … more
- CSL Behring (King Of Prussia, PA)
- …program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the ... applied to study design and data analysis for clinical trials and regulatory submissions + Influence and contribute to clinical development plans, collaborate with… more
- Merck & Co. (North Wales, PA)
- …of the teams executing processes according to SOP to meet global regulatory and internal standards. Champions Continuous Improvement Leads or supports initiatives ... that enhance processes, tools, and team agility. Stays Ahead of Innovation Tracks advancements in AI, automation, and clinical trial operations to guide tool selection and process optimization. Influences Technology and Workflow Decisions Contributes to… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health. Responsibilities : This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. This may include leadership of… more
- Merck & Co. (North Wales, PA)
- …function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and ... associated documentationEnsure programmatic traceability from data source to analysis/modeling resultSupport the development of programming standards to enable efficient and high-quality production of programming deliverablesProvide technical consultation and… more
- Bayer (Saxonburg, PA)
- …Finished product packaging using visual work instructions according to all regulatory requirements; Completion of all required transactional steps to receive and ... ship material; Identifying, defining and implementing process improvement or cost savings activities. WHO YOU ARE Bayer seeks an incumbent who possesses the following: REQUIRED QUALIFICATIONS High school diploma or GED; 1+ years experience in materials,… more
- Bayer (Saxonburg, PA)
- …suppliers, as needed, to ensure all quality controls are in place and all regulatory requirements are met. This position will also work with Suppliers who are issued ... corrective actions to help improve operations quality controls to ensure uninterrupted supply of quality materials. This position also works closely with the Supply Center Manufacturing and Supply Chain to pro actively identify any issues. In addition, the… more
- Bayer (Saxonburg, PA)
- …Finish product packaging using visual work instructions according to all regulatory requirements; Complete all required transactional steps to receive and ship ... material. Required Qualifications: High school diploma or General Educational Development (GED); Demonstrate working knowledge of MicroSoft (MS) Office applications; Able to operate independently; Demonstrate problem solving abilities; Support strong attention… more
