- Merck & Co. (Rahway, NJ)
- …global and site-specific projects, including those related to Combination Products and Drug Delivery Systems. The role includes leading, enabling or consulting in ... regard for all of our Company divisional and local site procedures for safety , quality, and regulatory compliance- Understand the big picture, and how activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant pharmaceutical industry experience in clinical development or clinical safety /post marketing safety in the pharmaceutical industry requiredMust ... expectedness of the adverse event in relation to the drug . Ensure all relevant data and findings are incorporated...have at least 4 or more years of pharmaceutical industry expertise in clinical safety /post marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …required Experience Qualifications- Must have 4+ years of professional clinical safety expertise from pharmaceutical industry, regulatory agency or academia, ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety , will be a product safety lead… more
- Merck & Co. (Rahway, NJ)
- …aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product ... on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs)… more
- Merck & Co. (Rahway, NJ)
- …part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and ... and biologics. The group supports various cell bank and upstream drug substance process commercialization activities and second generation process development… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Decision Making, Drug Product Manufacturing, Environment Health and Safety , Global ... Manufacturing Processes, Manufacturing Scale-Up, Manufacturing Support, Occupational Health and Safety Management, Pharmaceutical Manufacturing, Regulations, Regulatory Compliance… more
- Merck & Co. (Rahway, NJ)
- …across many diverse areas including Biological, Chemical, Automation, Safety , Technical Services, Process Development, Analytical, Regulatory, and Quality.As ... part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and technology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the investigational sites. Additionally, this position possesses adequate knowledge of drug development in pharmaceutical industry across different disease ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Eisai, Inc (San Jose, CA)
- …and management preferred.Experience working with key laws and regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food, Drug , Cosmetic ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of… more
- Merck & Co. (Rahway, NJ)
- …lead multidisciplinary program teams. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... deep cell culture subject matter expertise, a strong understanding of drug commercialization and the regulatory landscape.In this role, the successful candidate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of… more
- Merck & Co. (Durham, NC)
- …seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical , Biologic, and Vaccine Products. Our team works with a " Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs,… more
- Merck & Co. (Boston, MA)
- …is responsible for implementing capabilities and associated services to advance the drug discovery and development pipeline. Our IT team operates as a business ... and external tools. Work with external vendors of genomics, molecular biology, safety and target discovery tools and data to assess opportunities and facilitate… more
- Eisai, Inc (Exton, PA)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production… more
- Eisai, Inc (Milwaukee, WI)
- …and management preferred.Experience working with key laws and regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food, Drug , Cosmetic ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Merck & Co. (South San Francisco, CA)
- …2+ years) in Biochemistry, Biophysics or a related field with relevant drug discovery experience in a biotech/ pharmaceutical setting Required Experience and ... and functional assays as well as mechanistic experimentation to advance early drug discovery projects across various modalities. The candidate will work closely with… more
- Merck & Co. (Rahway, NJ)
- …(GMP) and Safety compliance regulations.Must possess ability to convert new drug product attributes and process needs to an executable series of steps and ... Requirement: Master's degree in Chemical Engineering, Chemistry, Industrial Engineering, Pharmaceutical Sciences or closely related scientific field with 2 years… more
- Genmab (NJ)
- …are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the ... committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight of programming activities… more
