- Parexel (Trenton, NJ)
- … regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer Regulatory Systems & Reporting - Experience with CPP application filing via ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...eCATS and 510(j)(3) reporting through nextGen portals is a plus - Ensure… more
- Parexel (Trenton, NJ)
- …processing for studies including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and concerns ... review of various documents which might be audited by clients and regulatory agencies More generally in any client interactions: --Provide medical expertise and… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review current reporting period against historical ... medical standpoint, identify and respond to signal analysis, and submit to regulatory agency (FDA/Health Canada) within timelines to achieve 100% compliance with US… more
- Sandoz Group AG (Princeton, NJ)
- …regulations. Responsible for the execution of processes related to Health Authority reporting for Sandoz in accordance with Sandoz Quality procedures and US ... regulations. Responsible for the execution of processes related to Health Authority reporting for Sandoz in accordance with Sandoz Quality procedures and US… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …that our global workforce is bound by our common values. **Job Summary:** Reporting to the Chief Commercial Officer, US Innovative Medicines, the Senior Director of ... with IT, compliance, and external vendors to ensure data integrity, privacy, and regulatory adherence. + Immersion in strategic and tactical plans of the US… more
- Integra LifeSciences (Princeton, NJ)
- …strategy. This role ensures compliance with best practices, legal and regulatory requirements, optimizes software licensing, and manages vendor relationships to ... to develop software budget forecasts and track expenditures. + Stakeholder Collaboration & Reporting : + Act as a key advisor to senior leadership on contract and… more
- BeOne Medicines (Pennington, NJ)
- …continued process verification, investigations, change management and manufacturing startup. Reporting to the MST leadership, this role is responsible for ... + Manage and coordinate global change ensuring stakeholders alignment. Assist in Regulatory filings and Health Authority site inspections to license and maintain… more
- Integra LifeSciences (Princeton, NJ)
- …strategic decisions.. + Compliance: Ensure all suppliers adhere to relevant regulatory requirements and industry standards, including ISO and FDA regulations. + ... Reporting : Support the preparation of regular reports on supplier...understanding of supply chain principles, quality assurance processes, and regulatory requirements in the medical device field. + Excellent… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects + Ensure that all aspects of the quality ... all associated design control documents in accordance with project, industry and regulatory requirements + Contribute to new and supplemental regulatory … more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …oversight for direct and indirect reports. + Partner with Sales, Supply Chain, Regulatory , Quality, and Finance to align on strategic initiatives. + Support business ... etc. Supporting continuity across key marketing and customer service activities. Reporting & Governance: + Develop and maintain dashboards for launch performance,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …capabilities across planning, logistics, and operations within the North American region. Reporting to the Head of Supply Chain & External Manufacturing NA, this ... + Strong knowledge of ASCM SCOR framework, Gartner Maturity Model, and NA regulatory landscape. + - Proven success in capability building, talent development, and… more
- BeOne Medicines (Pennington, NJ)
- …and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day ... DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations. + Ensure appropriate… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …code application and approval process working closely with government pricing and regulatory teams. + Work closely with the finance team to establish rebate ... contracted stakeholders. + Develop and present financial impact analysis and other ad-hoc reporting as needed to senior management. + Leads the yearly review of… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …organization (ie Sales, Pricing & Contracts, Supply Chain, Finance, Regulatory and Government Pricing). **Duties and responsibilities** 1. **Contract Negotiations:** ... with Sales directors, to review and approve claims in a timely fashion 1. ** Reporting and Analytics/ SAP / VISTEX OTC Team Lead:** + Review Broker commissions… more
- MISTRAS Group, Inc. (Princeton Junction, NJ)
- …+ **Market and Industry Expertise:** + Stay informed about industry trends, regulatory changes, and competitive landscapes in the oil and gas market. Knowledge ... improve service offerings based on customer needs. + **Performance Metrics and Reporting :** + Develop key account plans and track key performance indicators (KPIs)… more
- Tris Pharma (Monmouth Junction, NJ)
- …monthly, quarterly and annual consolidated financial statements; Assists with regulatory reporting , as applicableResearches and corrects accounting issues ... support in ensuring company financial records remain accurate while meeting reporting deadlines. The incumbent establishes and approves internal controls and… more
- Merck & Co. (Upper Gwynedd, PA)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication. -- Responsibilities: Specifically, the ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting , publication, and presentation at national and ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Public Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key relationships in NN/AS ... opportunities; and works with reporters to ensure accurate media reporting Leads communications excellence activities that contribute to leadership development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
