- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (North Wales, PA)
- …readiness as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Parexel (Trenton, NJ)
- …will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission ... presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. ** Project...level of training or performance of team members on project work. Provide line manager with input… more
- Parexel (Trenton, NJ)
- …members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a ** Senior Physician in ... and discussing issues related to review process with Line Manager / Project Leader/Designee + Interacting with internal...and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities… more
- Parexel (Trenton, NJ)
- …content review. **Document Project Management** + Act in the capacity of project manager /lead for medical writing projects, which may entail serving as the ... **Job Summary:** The Senior Medical Writer will research, create, and edit...and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical… more
- Parexel (Trenton, NJ)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more
- BeOne Medicines (Pennington, NJ)
- …effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ ... the ability to work accurately in a busy and demanding environment. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- **Job Summary** We are seeking a results-driven Senior Manager , Sales Training of Integrated Delivery Network, Reimbursement & Oncology to lead our learning and ... with a keen knowledge of the 5 Ds and project management. - Conduct training needs assessments to identify...and enhance their overall performance. 7. **Market Insights and Regulatory Awareness:** - Stay informed about industry trends, competitive… more
- Parexel (Trenton, NJ)
- …in assigned studies and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction Business ... in study planning with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA… more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The Manager , Contracts and Vendor Management, is responsible for overseeing the Information System's ... strategy. This role ensures compliance with best practices, legal and regulatory requirements, optimizes software licensing, and manages vendor relationships to… more
- WuXi AppTec (Plainsboro, NJ)
- …the success of new and existing services. This position will report to the Senior Director of Business Development, TIDES Discovery, and will help to support TIDES ... members to complete RFQ/RFPs + Work closely with all WuXi business units, project management teams, and marketing to ensure coordination of efforts and ensure good… more
- Organon & Co. (Lansdale, PA)
- …team members to maximize appropriate utilization of Organon products. Integrates Senior Leadership into the overall business relationship at the regional level, ... together and Keep moving. + Ensures proper diligence on policy, legal, regulatory , and company compliance issues. **Required Education, Experience and Skills** +… more
- Ascendis Pharma (Princeton, NJ)
- …mark. We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of Global ... Affairs and 3 years of experience performing directly relevant Regulatory Project Management activities within the pharmaceutical and/or biotechnology… more
- TD Bank (Mount Laurel, NJ)
- …general direction, quality control and subject matter expertise to the team + Senior Manager providing advisory services to executives, business segment leaders ... maintaining TD's US Recovery and Resolution Plans and other regulatory submissions, as required under the Dodd-Frank Act and...new regulations, and maintaining US RRP rule federation. The Senior Recovery and Resolution Planning Manager manages… more
- TD Bank (Mount Laurel, NJ)
- … submissions, as required under the Dodd-Frank Act and other applicable regulations. The Senior Manager II, Recovery and Resolution Planning oversees a team of ... growing talent, developing skills and capabilities to achieve career goals, support project / initiative success and achieve business results + Develops appropriate… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. -… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory ... on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC… more
- AECOM (Philadelphia, PA)
- …**Job Description** The Water Division of AECOM is actively seeking a creative, Water Design-Build Senior Project Manager . This position will be part of an ... depending on project workload.** **Job Responsibilities:** The Senior Project Manager will be...preferred + Experience in working with local and state regulatory agencies + Experience in managing both engineering and… more
