- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team ... Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...and supportive documentation for FDA briefing packages Work with project leader and team to draft FDA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during ... (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project...endorsed by GPT and other governance bodies.Serve as a leader of the GRT (Global Regulatory Team)The… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …knowledge and knowledge of the region to enhance territory management of field teams Lead project teams to manage and support various projects such as digital ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...This position may report into the Field Director, Medical Affairs (or in smaller TA's directly into the TA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience in project management. Pharma experience preferred Demonstrated ability to lead and work within a cross functional team; ability to form effective ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Project Manager, Accelerated Efficiencies and Optimization, will drive execution… more
- Merck & Co. (Rahway, NJ)
- …(eg, CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling ... regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of...Affairs , Clinical, Pharmacovigilance).- - Required experience and skills: Project management skills with the ability to handle multiple… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to navigate regulatory ... analytics and software tools Experience with management of external partners Strong project management skills to lead and oversee multiple initiatives from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...are likely to benefit from our therapeutics.Responsibilities- Leads CDx project teams for the diagnostic, in full alignment with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical ... serve as G-RACMC lead or regional submission lead . Provide regulatory guidance and strategy to...in scientific/ regulatory fields required- Experience in international Regulatory Affairs - CMC preferred Daiichi Sankyo, Inc.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …professionals at strategic non- project team and at CSPV strategic discussions.Take the lead as the Head of PV QA with Quality Reviews of respective product ... key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever...and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient… more
- Merck & Co. (North Wales, PA)
- … regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges ... and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, Medical...to the Director, Medical Operations, Innovation and Emerging Projects Lead .The AD, IEP is an integral member of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Merck & Co. (Rahway, NJ)
- …This role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with International ... and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned studies: pro-actively plans, drives and-tracks… more
