- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF ... risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** Regulatory Affairs ** and… more
- Merck (Rahway, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck (Rahway, NJ)
- …with cross-functional teams, including research, development, quality control, and regulatory affairs , to ensure comprehensive biophysical characterization of ... Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Bristol Myers Squibb (Princeton, NJ)
- …projects. + Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them. ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command of US… more
- Actalent (Branchburg, NJ)
- …and labeling requirements to internal stakeholders. Essential Skills + Expertise in regulatory affairs , labeling, and quality assurance. + Experience in document ... Skills & Qualifications + Bachelor's degree in Chemistry, Environmental Science, Regulatory Affairs , or related field. + Minimum of 3 years of experience… more
- Merck (Rahway, NJ)
- …of best practices in those areas + US/Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical policy ... , Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory Affairs … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Hackensack Meridian Health (Edison, NJ)
- …is responsible for shaping and executing the health system's state and federal regulatory affairs strategies, and for ensuring that HMH maintains productive, ... required. + Minimum of 15 years of progressive experience in government affairs , regulatory affairs , or health policy, with significant exposure to state… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory … more