- Merck & Co. (Rahway, NJ)
- Job Description Responsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis /modeling datasets, tables, listings, figures… more
- Merck & Co. (Rahway, NJ)
- …analysis requirements, internal standard operating procedures, validation, and external regulatory requirements.6. Evaluates appropriateness of available ... analysis , and interpretation posed by the clinical monitors, regulatory agencies, or investigators.-10. Responsible for ensuring the accuracy of Statistical… more
- Insmed Incorporated (NJ)
- … external labs operate in full compliance with cGMP, regulatory expectations, and Insmed quality standards. Support inspection readiness and provide ... distribution).Lead and approve deviation investigations, OOS, and OOT results generated by external labs. Ensure thorough root cause analysis and appropriate… more
- Merck & Co. (Upper Gwynedd, PA)
- …entire cycle of clinical development, including study design, placement, monitoring, analysis , regulatory reporting , and publication. -- Responsibilities: ... clinical study reports, or publication; and participating in internal and joint internal/ external research project teams relevant to the development of new compounds… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including study design, initiation, execution,-monitoring, analysis , regulatory reporting , publication, and presentation ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- ExxonMobil (Spring, TX)
- …groups + Ensure Business Units understand new and changing rules timely, ie Regulatory Analysis , and support Business Units in developing compliance plans ... development. **What role you will play in our team** Join ExxonMobil as a Regulatory Affairs Advisor supporting the Permian Business Unit. Become part of a team… more
- CSL Behring (King Of Prussia, PA)
- …that make a meaningful difference worldwide. Could you be our next Senior Manager, Regulatory Science? The job is in our King of Prussia, PA office. This is ... onsite three days a week. You will report to the Head of Global Regulatory Science and Policy. **Position Description** **Summary** The primary purpose of this role… more
- Mission Support and Test Services (Mercury, NV)
- …**Responsiblities** Radiological Control Department is seeking a self-motivated Radiological Regulatory Compliance Specialist I to work with our senior compliance ... professional to maintain regulatory and contractual requirements within the Radiological Control organization. **Key Responsibilities** + Performs work of limited… more
- Genmab (NJ)
- …CDISC standards and other industry standards that supports the exchange of data, reporting , and analysis . Ensures alignment of SDTM standards with data ... development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications… more
- Merck & Co. (Rahway, NJ)
- …reporting and analysis of clinical samples, both internally and with external vendors in compliance with the relevant regulatory and quality standards. ... sections of regulatory filings (eg IND, BLA) as needed and external scientific publications summarizing data and present findings to clinical and other internal… more
