- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly ... a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for...execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs,… more
- Merck & Co. (Durham, NC)
- …on all the programs described above. Reports to the site's Executive Director of Engineering, Maintenance and Site Services. GENERAL PROFILE Provides leadership and ... departmentExecutes functional business plans and contributes to the development of group or country strategiesPriorities based on departmental budget and profit plan… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... when necessary, through formal or informal presentations-Stays current in technology and regulatory changes both within and outside of our companies that may impact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … authority requests or communicationEnsures consistent and unified safety message throughout multiple documentsCTD submissions/Others:Collaborates with the PSL(s) ... a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global… more
- Merck & Co. (Boston, MA)
- …DescriptionWe have an exciting opportunity for a physician-scientist to join our group as a- Principal Scientist (Clinical Director ) in Translational ... We are seeking a highly qualified individual for a position in our group . Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions (phase I trials) Provide safety input… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... and a robust pipeline of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Computational Toxicology group within the Nonclinical Drug Safety (NDS) division at our company is actively seeking an enthusiastic AI/ML data ... at the forefront of AI/ML application and data science methodologies towards drug safety prediction.Note: This position is available in South San Francisco, CA or… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may ... Scientists in the execution of clinical studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety )Assist regulatory groups by providing ... Durham site.-- The successful candidate will report to the Associate Director , Laboratory Operations to lead start-up new laboratories for microbiological testing… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be ... Scientists in the execution of clinical studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and… more
- Martin Luther King, Jr. Community Hospital (Los Angeles, CA)
- …peers and staff.Maintains a safe and clean environment that complies with regulatory standards including Patient Safety Goals.Participates in the implementation ... on the Watson Model of Care for a defined group of patients, including the identification and demonstration of...or Critical Care nursing experience preferred with regard to regulatory guidelines and standard of practice and/or at the… more
- Martin Luther King, Jr. Community Hospital (Los Angeles, CA)
- …and staff. Maintains a safe and clean environment that complies with regulatory standards including Patient Safety Goals. Participates in the implementation ... on the Watson Model of Care for a defined group of patients, including the identification and demonstration of...forms and reports findings to the Charge Nurse and Director of Perioperative Services. POSITION REQUIREMENTS A. Education Bachelor… more
