- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... low to medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, data surveillance review ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …principals and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support ... & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in sales, sales training, and marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.Develop,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Insmed Incorporated (Bridgewater, NJ)
- …monitoring remediation, and support in developing guidance documents and training. The Manager , US Compliance reports to the Senior Director, US ... fun? Yes? Then maybe you will be our next Manager of US Compliance! This role will implement day-to-day...Speakers Bureau program, including but not limited to the review of program materials, oversight of Speaker selection process… 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)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That strategy will… more
- Publicis Groupe (New York, NY)
- …clients) follow the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a key role in establishing ... for identifying and solving potential issues across their account(s). Additionally the Senior Manager , Regulatory Review must traffic, manage and assign… more
- Publicis Groupe (New York, NY)
- …and effort required to create various components of each submission for a Manager , Regulatory Review or Senior Associate, Regulatory Review + ... Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Associate, Regulatory Review works closely with the internal… more
- Scotiabank (New York, NY)
- Senior Manager , Regulatory Technology **Requisition ID:** 198629 **Salary Range:** 110,700.00 - 211,800.00 _Please note that the Salary Range shown is a ... every future! **Purpose** This role will serve as a Senior Manager in the Technology Governance Office,...auditors on tracking remediation action plans. + Draft and review regulatory responses; provide oversight, feedback, and… more
- TD Bank (New York, NY)
- …management within the Bank to further RPM's mandate + Leads discussions of Regulatory Review Council related to assigned business lines and participates in ... role. **Line of Business:** Risk Management **Job Description:** The Regulatory Relationship Manager II provides strategic oversight,...various Senior and Executive level review or oversight… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …external questions regarding drug products. **Position Summary / Objective** The Senior Manager , GRS-CMC is responsible for content development, compilation, ... meetings); &/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary...Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Senior Manager , US Advertising & Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** Under the ... Director, this individual will be responsible for providing US regulatory review and approval of promotional and...meet both short- and long-term growth targets. Consults with senior management and provides input to the Global organization… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to industry organizations, Health Authorities and other stakeholders + Facilitate regulatory intelligence review meetings and/or lunch-n-learn sessions + ... and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through… more
- Grant Thornton LLP (New York, NY)
- As a Regulatory Compliance and Operational Risk Senior Manager , you will get the opportunity to grow and contribute to our clients' business needs by ... to provide comprehensive compliance optimization strategies, to help clients remediate regulatory gaps, streamline operations and limit risk exposure. From day one,… more
- Revlon (Edison, NJ)
- …and Green Chemistry initiatives, eg Retailer Sustainability/'Clean' Beauty Initiatives + Regulatory review and approval of product claims + Partner ... consumers. We are Revlon, together, transforming beauty. **Major Duties:** o Provide Regulatory compliance, guidance and support, including but not limited to: +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC-RA, will review and… more
- Bristol Myers Squibb (Summit, NJ)
- …and growth of the Material Review Board lead and associates. The Senior manager participates in continuous MRB process initiatives and represents the Summit ... here at BMS with our Cell Therapy team. The Senior Manager is a people leader responsible...the QA team that coordinates and leads the Material Review Board (MRB) meetings for commercial and clinical products… more
- L'Oreal USA (Clark, NJ)
- …requirements. As a Senior Scientist - Regulatory in our Regulatory team, your main responsibilities are: + Review formulations to ensure compliance ... Home (https://careers.loreal.com/en\_US/content/Home) / Job Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 182084 Senior Scientist I, Regulatory Affairs, L'Oreal… more
