- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and ... Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than...lifecycle management activities for device aspects of combination product submissions . + Contribute to product development planning, including strategies… more
- Fiserv (Berkeley Heights, NJ)
- …agreements with strategic bank partners and merchants. You will also provide regulatory advice on laws and rules impacting our merchant business, including BSA/AML, ... with corporate specialists regarding credit, risk, compliance, finance, audit, tax, regulatory , privacy, and technology matters that impact the Merchant Solutions… more
- Fiserv (Berkeley Heights, NJ)
- …compliance activities such as monitoring and testing, risk assessments, regulatory rules management, policy management, compliance training, and overall Compliance ... Program metrics and reporting. This role will initially focus on the Regulatory Rules Management (RRM) program, with the potential for expanded responsibilities in… more
- Fiserv (Berkeley Heights, NJ)
- …of Fiserv's data, facilitating strategic decision-making and ensuring compliance with regulatory requirements. **What you will do:** + Draft policies, standards, and ... and implementing data governance practices across organizations. + Experience with regulatory compliance and audit processes in the field of data management.… more
- Fiserv (Berkeley Heights, NJ)
- …the business through appropriate ACH/Nacha change management, keep a close watch on regulatory developments in ACH, and act as a strong advocate and champion for ... of senior leaders. **What would be great to have:** + Certified Regulatory Compliance Manager certification (CRCM) or Juris Doctor (JD). **Important information… more
- Virtua Health (Marlton, NJ)
- …requirements. Job Summary: Supports the IRB by triaging and managing submissions through a pre-review process for completeness. Supports the research community ... by providing policy and regulatory guidance and ensures studies are complete before being...filing deadlines are met. Position Responsibilities Responsible for moving submissions through the IRB workflow process in a timely… more
- Fiserv (Berkeley Heights, NJ)
- …preparing, framing and delivering formal cybersecurity responses to internal auditors, regulatory bodies, and auditing firms across the globe. Our team safeguards ... are responsible for internal audit facilitation, external audit response and regulatory response. + Collaborate with cross-functional teams to understand controls. +… more
- Sumitomo Pharma (Trenton, NJ)
- …in risk mitigation strategies preferred. + Experience preparing safety reports and submissions to FDA, EMA, and/or other regulatory authorities. + Effective ... Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses. + Contribute to signal… more
- J&J Family of Companies (Titusville, NJ)
- …for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality ... quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs,… more
- Fiserv (Berkeley Heights, NJ)
- …and external sources including assessing Fiserv Standards for adherence to new/changed regulatory requirements and industry standards + Oversee delivery of plans to ... evaluation, and risk assessments + Maintain a reference library of authoritative regulatory and industry sources used to maintain the document set/related glossary +… more
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