- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …JD) preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …gathering that also accounts for nuances between different world regions and addresses regional regulatory needs and priorities (eg through collaboration with ... for collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. Regulatory PolicyScans the horizon… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... within CSPV function. Improve QA engagement with CSPV at the global, regional , and local level pertinent to metrics, lessons learned and improved processes.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs to support the business functions of Daiichi Sankyo (DS) in the US , EU, Japan, and other global sites. These business functions include: Clinical ... Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Insmed Incorporated (Bridgewater, NJ)
- …to-be-marketed productsResponsibilitiesIn close collaboration with Regulatory project leads in the US , EU, and Japan, the Director , Regulatory Labeling ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...Workplaces for Millennials™ lists.OverviewThis is a key role providing regulatory expertise and guidance to internal stakeholders for successful… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the Brand team for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible for ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... as well as preparing for, management and follow up of regulatory inspections. Primary Duties: Operational Quality Management: Overseeing the strategic implementation… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... will focus on oncology products.Under the direction of a HEDS Senior Director , the Principal Scientist provides strategic development and use of industry-leading… more
- S&P Global (New York, NY)
- …law. BSMGMT202.2 - Middle Professional Tier II (EEO Job Group) **Job ID:** 298786 **Posted On:** 2024-04-30 **Location:** New York, New York, United States ... to contracted standards. **Compensation/Benefits Information (This section is only applicable to US candidates):** S&P Global states that the anticipated base… more
- Bristol Myers Squibb (Trenton, NJ)
- …goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . **Associate Director , Clinical Nurse Consultant** _The Clinical ... Nurse Consultant (CNC) Associate Director is the leader of a US ...of integrity and dependability + Current working knowledge of US legal, regulatory , and compliance regulations and… more
- Ascendis Pharma (Princeton, NJ)
- …activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as ... The Regulatory Affairs (RA) Associate Director , Labeling...Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for… more
- HSBC (New York, NY)
- …trait protected by applicable law. **Job Field:** Commercial Banking **Primary Location:** North America- United States -New York-New York **Req ID:** 0000K7XK ... receive payments and manage their liquidity across borders and regulatory jurisdictions, in multiple currencies. This role is responsible...Securities Services, Hedge Funds, Private Equity etc. As our Director - Regional Head of NBFI Sales… more
