- Novo Nordisk Inc. (New York, NY)
- 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
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... "Win as One Team"Development of content or activities for global and regional workshops and meetingsCreate a culture of openness, collaboration, focus and… more
- Merck & Co. (Rahway, NJ)
- …in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the late lifecycle ... late lifecycle opportunitiesSupport filing of new indications and other regulatory requirements, such as pediatric filingsCross-functional collaboration: foster strong… 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 experience requiredExperience… 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
- 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
- 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)
- …Daiichi Sankyo, and where applicable, partner companies for the development and approval of US , EU and global CCDS documents for regulatory filings and HA ... More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience… 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)
- …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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Trial Information Disclosure Manager leads company operational activities to comply with US , EU, Japan and other regional disclosure regulations and the ... company initiatives, strategies and operational activities to comply with the US , EU, Japan and other regional trial disclosure regulations… more
- Pfizer (New York, NY)
- …a Director to join our vaccines Global Regulatory Science team as a US Regional Regulatory Strategist (RRS). This is an excellent opportunity to join ... This is an individual contributor role. **ROLE RESPONSIBILITIES** * Accountable for ensuring US regional contribution to Global Regulatory Strategies and… 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
- Pfizer (New York, NY)
- …with Health Authorities in relation to the assigned project(s). Role may be combined with other Regulatory Role (ie regional US or EU regulatory role ... Director , Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional ...an E-Verify employer. This position requires permanent work authorization in the United States . Regulatory … more
- Bristol Myers Squibb (New York, NY)
- …medical education, data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...phases of associated clinical trials. The RAD oversees their regional team to ensure disease and product related medical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Oncology and Precision Medicine, and collaborate with the biomarker team and global/ regional regulatory liaisons to provide Precision Medicine global ... Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross- regional Regulatory Teams and other Sub-teams involved with the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to the terms and conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer, Gilead Sciences Inc. is committed ... who are responsible for managing core labeling (CCDSs) and US labeling (USPIs) and for oversight of regional...position, and in close collaboration with cross-functional global and regional stakeholders, to support regulatory filings and… more
