- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with… more
- Merck & Co. (Rahway, NJ)
- …Affairs and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director ) and/or Distinguished ... Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …and negotiate with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... direct reports, and mentors or acts as functional manager of skip-level or ex- US staff. This position requires strong knowledge about RBQM, and related processes,… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director...development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionRole SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has...development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by… more
- Eisai, Inc (Nutley, NJ)
- …the product lifecycle. Provide senior staff advice and guidance on regulatory issues, especially for US . Responsible for oversight and strategic planning ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and...the employment eligibility of all new hires in the United States . Please click on the following… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... stakeholders. The role will manage and or support medical affairs Quality resources ( US , Brazil, Japan/ APAC and EU):in an efficient and effective manner including,… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... the Customs & International Trade (CIT) Tariff Classification Associate Director , the Senior Specialist will work closely...on the use of certain special tariff provisions for US imports;Interface with global regulatory and others… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... to the Customs & International Trade (CIT) Valuation Associate Director , the Senior Specialist position's core responsibilities...CIT is also responsible for the management of the US - Proof of Payment process ensuring that the customs… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing...across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...scientific role tasked with working closely with the group Director to define group strategy and to lead a… more
- Mount Sinai Health System (New York, NY)
- **Job Description** **System Senior Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is ... reports to external agencies. + Works on other regulatory projects and duties as assigned. **About Us... regulatory projects and duties as assigned. **About Us ** **Strength through Unity and Inclusion** The Mount Sinai… more
