- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … research areas centered around rare diseases and immune disorders.SummaryThe Associate Director, Regulatory Operations - Dossier Planning is responsible for ... including, but not limited to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory Operations in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director, Research Partnerships (RP) is responsible for developing and executing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Associate Director RP will be the lead for research within a specific therapeutic area (eg, obesity, diabetes,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. ResponsibilitiesEnsure global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Novo Nordisk Inc. (WA)
- …if relevant Novo Nordisk experience is demonstrated in GCP-related clinical research Bachelor's degree required* ( science related discipline preferred): ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Merck & Co. (Durham, NC)
- …with our core principle of Safety First and Quality Always.The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing ... unit operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in one or more key functions (eg clinical operations, clinical research , clinical science , and/or CQA). Strong experience in procedural writing ... process experience in one or more key functional areas (eg clinical research & development, clinical science , clinical quality assurance, project management)… more
- Merck & Co. (Rahway, NJ)
- …drug products.Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile and ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Build deep fundamental knowledge around the drug product… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our companies renowned Research and Development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate … more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Merck & Co. (North Wales, PA)
- Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people around the globe. We are ... currently recruiting for Associate Director, US Marketing, HCP Strategy for HIV. Our...for HIV. Our company has been committed to advancing science for the treatment and prevention of HIV for… more
- Merck & Co. (North Wales, PA)
- …tables, listings and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport ... programming deliverablesproduce SAS transport files and associated documentation for regulatory submissionsRepresent statistical programming on process improvement activities Education… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Merck & Co. (Rahway, NJ)
- …new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be responsible for delivering SAP solutions to our ... Research Organizations' Global Clinical and Ancillary Supply-user community. You...operations, distribution, ensuring compliance with market requirements as global regulatory requirements continue to evolve. Develops subject matter expertise… more
- Merck & Co. (North Wales, PA)
- …of the role Preferred Experience and Skills: Ability to translate science /clinical data into clear marketing strategies, medical education and/or conference ... review processes) including experience including bringing materials through legal, regulatory , and clinical review Strong project management skills as demonstrated… more
- Aequor (Thousand Oaks, CA)
- …PQ owned regulatory filing sections and RTQs? Provide expertise in science and risk-based evaluation of complex process and product quality data, including ... executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory , Process Development, Quality Assurance, and other functional areas… more
- Insmed Incorporated (San Diego, CA)
- …where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were ... for the development programs for products in a global, matrix organization, from Research to life cycle management. Additionally, the Associate Director of PM… more
