- 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)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan… 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)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… 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
- Merck & Co. (North Wales, PA)
- …requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement the regulatory ... Work Experience Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective ... clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will...monitoring under direct guidance of a physician (Global Clinical Leader or Physician Scientist). The clinical science lead… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure sucessful implementation of CDx and data collectionSupports 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...who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and… 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)
- … 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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior ... and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input… 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
