- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Tris Pharma (Monmouth Junction, NJ)
- …New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) ... Senior Scientist I, under minimal guidance, performs...in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist /Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist /Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products ... strategies and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory… more
- Cambrex High Point (High Point, NC)
- …world. Start a career where You Matter by applying today! Job Overview The Senior Scientist , Regulatory Compliance will provide oversight of regulatory ... GXP/QA/ regulatory compliant pharmaceutical laboratory environment or Quality Assurance/ Regulatory Affairs role (prefer late phase/commercial experience).… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will ... regulatory strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate innovative regulatory… more
- Lilly (Indianapolis, IN)
- …life-changing new medicines to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small ... the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage innovative … more
- Abbott (Santa Clara, CA)
- …This position will work closely with the clinical study team including regulatory affairs , project management, biostatistics, data management, and other clinical ... holders including clinical project management, clinical operations, biostatistics data management, regulatory affairs , medical affairs , and external stake… more
- Merck (South San Francisco, CA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Danaher Corporation (Sunnyvale, CA)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Clinical Research Scientist reporting to ... commercialization of products. This position is part of Clinical Affairs and will be an Onsite Role in Sunnyvale,...will be an Onsite Role in Sunnyvale, CA. The senior clinical research scientist will work on… more
- DEKA Research & Development (Manchester, NH)
- DEKA Research & Development has an immediate opening for a Biocompatibility & Toxicology Senior Scientist to join our team focused on medical device and ... this role will work directly with Research & Development, Regulatory & Clinical Affairs and Quality Engineering...will make a difference as a Biocompatibility & Toxicology Senior Scientist : + Work in close association… more
- J&J Family of Companies (Cincinnati, OH)
- …States of America **Job Description:** We are searching for the best talent for a ** Senior Scientist - MedTech Surgery** to be in **Cincinnati, OH** . _This role ... 5 days per week in-office_ . **Purpose** : The Senior Scientist /project leader in Preclinical Research will...Preclinical Research group. + Works cross functionally with Medical Affairs , Safety, Regulatory , and Quality to assess… more
- J&J Family of Companies (Raritan, NJ)
- …at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine is hiring a Senior Scientist , Biostatistics to be located in either Raritan, ... NJ, Spring House, PA, or San Diego, CA. The Senior Scientist , Biostatistics will support the Oncology...internal SAS programmers, clinical trial managers, and personnel from regulatory affairs , medical writing, and other disciplines… more
- Sumitomo Pharma (Lincoln, NE)
- …benefit-risk assessment. + Collaborate with colleagues in Clinical Development, Regulatory Affairs , Biostatistics, Data Management, and other departments. ... follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The Senior Manager, Pharmacovigilance Scientist serves as the… more
- Steuben Foods Inc (Elma, NY)
- The position of Senior Food Scientist / Senior Product...of Food Safety + Up to date knowledge in Regulatory affairs & Labelling laws + Analytical, ... other key meetings as a technical support role + Stay up to date on Regulatory Affairs and changes in the Food and Beverage labeling sectors + Work closely with… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Pharmacovigilance (GPV), TAs, Translational Medicine and Clinical Pharmacology (TMCP), and Global Regulatory Affairs (GRA). Represent BI for regulatory ... **Description** Senior Clinical Data Scientist at Boehringer...and, working with the pharmaceutical industry, Contract Research Organizations, regulatory authorities, or academic institutions. 20% domestic and international… more
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