- Actalent (New Brunswick, NJ)
- …and as a Clinical Research Coordinator (CRC). + Strong understanding of clinical operations and regulatory compliance. + Bachelor's Degree in a science ... comprises 70 employees with diverse skill sets, including CRC, Regulatory Affairs, and Clinical Research Managers. We foster a collaborative culture where you… more
- Sanofi Group (Morristown, NJ)
- …The Associate Director contributes to early development activities by providing regulatory input into clinical development plans, including guidance on ... The Associate Director collaborates closely with cross-functional teams, including Global Regulatory Affairs, Clinical Development, Safety, and Medical Affairs,… more
- Sanofi Group (Morristown, NJ)
- …active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase ... regional labeling (eg, US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… more
- System One (Florham Park, NJ)
- …documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to ... are met. + Ability to work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the appropriate audience + Must be able to maintain confidentiality in dealing with regulatory and clinical documentation + Must be able to prioritize and handle ... you'll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus...your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused on maintaining… more
- Bausch + Lomb (Trenton, NJ)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... manage and monitor study related expenses to meet forecast. Regulatory Reports: + Provide Clinical Operations support in the timely coordination and execution of… more
- Sanofi Group (Morristown, NJ)
- …with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, ... SOPs, GCP, ICH guidelines and other regulations. + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for… more
- Vitalief (New Brunswick, NJ)
- …needed. + Facilitates clinical trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with Finance ... analysis and research of financial data and transactions. + Experience in clinical research administration; knowledge of regulatory , financial and administrative… more
- Bristol Myers Squibb (Princeton, NJ)
- …health and optimize product benefit-risk profiles. The ED works cross-functionally with clinical , regulatory , medical affairs, quality, and commercial teams to ... HTA submissions + Cross-Functional Leadership and Stakeholder Engagement + Partner with clinical , regulatory , and medical affairs teams to integrate safety… more
- Bristol Myers Squibb (Madison, NJ)
- …and advisory board meetings as Clinical Trial Physician + Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission ... personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** The Clinical Trial Physician sits within Clinical Development, which… more