- Merck & Co. (North Wales, PA)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance… more
- Merck & Co. (North Wales, PA)
- …- In addition, the candidate will be responsible to establish and lead cross-functional teams through the sourcing process and to provide strategy oversight ... with Target; participation in Market Intelligence activities in connection with Target; data gathering and analysis in connection with Target; others that contribute… more
- Organon & Co. (Plymouth Meeting, PA)
- … data science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), project management and other partner groups as part ... **Job Description** **The** **Position** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Parexel (Trenton, NJ)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About ... innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team....If you have a passion for clinical research, strong project management skills, and a knack for data… more
- CSL Behring (King Of Prussia, PA)
- …R&D Data Stewardship to join the team. **Main Responsibilities:** + Lead the implementation of data management frameworks, standards and best practices ... innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building...agreements. + Monitor data stewardship KPIs and data quality metrics, lead remediation and optimization… more
- BeOne Medicines (Pennington, NJ)
- …Manufacturing operations. This role drives business planning, financial control , performance monitoring, investment analysis, and decision support activities ... in our Hopewell, NJ office. **Essential Functions of the Job:** + Lead Finance team supporting Hopewell (NJ) Manufacturing and External Manufacturing Operations,… more
- Parexel (Trenton, NJ)
- …or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well ... to determine appropriateness of content/format for clinical writing. **Quality Control ** + Ensure that all work is complete and...Project Management** + Act in the capacity of project manager/ lead for medical writing projects, which… more
- CSL Behring (King Of Prussia, PA)
- …and controlled vocabularies with global regulatory requirements (eg, ICH, EMA, FDA)? + Lead governance of PV data and processes, ensuring consistency and ... and create greater impact for patients. With a streamlined, project -led structure and a focus on collaboration, we're building...week. You will report to the Head of R&D Data Excellence. You will establish and maintain global standards,… more
- Parexel (Trenton, NJ)
- …associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage ... of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control ** +...submission. ** Project Management** + Operate as the project lead writer/submission coordinator and primary client… more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile...required cross-functional Delivery Teams (DT) This position is a " Lead Author" or "Contributing Author" for: + key study… more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... you be our next Senior Director, Global Clinical Program Lead , Cardiovascular? The job is in our King of...support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile… more
- CSL Behring (King Of Prussia, PA)
- …accountable for the statistical deliverables within the program. Main Responsibilities: + Lead full scope of Biostatistics conduct for the responsible program within ... strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions + Influence and… more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... and engage readily with diverse stakeholders and Regulatory Authorities. You will lead a team responsible for continuous analysis of global documents and regulatory… more
- CSL Behring (King Of Prussia, PA)
- …accelerate innovation and create greater impact for patients. With a streamlined, project -led structure and a focus on collaboration, we're building a future-ready ... organizational redesign, and implement automation to enhance operational efficiency, data quality, and cost savings. Main responsibilities and accountabilities:… more
- CSL Behring (King Of Prussia, PA)
- …and data analysis for clinical trials and regulatory submissions. Lead components and fully support Biostatistics conduct in study design, protocol development, ... innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building...will report to the Director of Biostats. You will lead components of statistical contribution to a clinical development… more
- CSL Behring (King Of Prussia, PA)
- …subnational views + Implement a framework for integrating primary and secondary data sources to monitor performance and identify geographic trends across key ... tools/processes, identify areas of improvement, and share best practices related to data and reporting + Collaborate with field and account managers to support… more
- Parexel (Trenton, NJ)
- …including trial design, protocol and CRF development on specific studies + Lead production and quality control of randomization, analysis plans, statistical ... sections for inclusion in study protocols + Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and… more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... medical judgment for analysis and interpretation of clinical safety data . Strong product knowledge is needed for success in...products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the… more
- Meta (Trenton, NJ)
- …for a portfolio of Data Centers of strategic importance to Meta. The Project Controls Lead will act as technical subject matter expert overseeing ... Accounting, Sourcing and Operations Engineering. **Required Skills:** Project Controls Lead - Data Center Design, Engineering, and Construction… more
- Meta (Trenton, NJ)
- …Accounting, Sourcing and Operations Engineering. **Required Skills:** Area Project Controls Lead , Leased Data Centers Responsibilities: 1. Technical ... of critical strategic importance for Meta's infrastructure growth. The Project Controls Lead will not... project controls operations for the project 9. Approximately 25-50% travel to other Data… more
