- J&J Family of Companies (Titusville, NJ)
- …work with the CDTL, DAS lead and with functional partners from global medical affairs , health care compliance, legal regulatory , and other relevant groups. + The ... and for final protocols, clinical study reports, and clinical components of regulatory packages/submissions. He or she may delegate some of these responsibilities,… more
- AbbVie (Florham Park, NJ)
- …areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple ... of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting… more
- Colgate-Palmolive (Piscataway, NJ)
- …marketing, product development, implementation and support, supply chain, insights and regulatory affairs teams to translate consumer insights into actionable ... Ensure quality control, and leverage external expertise to drive innovation. + ** Regulatory Compliance and Safety:** Ensure strict adherence to all global … more
- Ascendis Pharma (Princeton, NJ)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Sanofi Group (Morristown, NJ)
- …qualified with: + Min 15 years of experience working in clinical development and/or regulatory affairs + Min 10 years of leading an internationally dispersed ... of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates and executes a… more
- J&J Family of Companies (Raritan, NJ)
- …Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs ; US Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business ... to prepare relevant sections of documentation and communication for regulatory agencies and HTA agencies to provide the necessary...Health or Health Services Research is required + A PhD , PharmD or MD is strongly preferred. + A… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be… more
- Sanofi Group (Morristown, NJ)
- …Our Medical function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to support patients' needs. ... You** **Education:** Advanced degree in a scientific discipline (MD, PhD or PharmD) **Experience:** + Significant immunology experience required (Gastroenterology… more
- AbbVie (Florham Park, NJ)
- …and innovations in drug development spanning trial design, monitoring and regulatory submissions, as well as post-marketing access. As a Senior Manager, ... of work may include clinical trials, patient safety, and global medical affairs . Senior Managers works independently in partnership with experts in multiple… more