- 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. (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
- 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. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT)
- …Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs , Patient Safety and Pharmacovigilance to implement ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Exponent Inc. (Washington, DC)
- …responsible for Providing technical expertise to our clients related to food science, regulatory affairs , product approvals (GRAS, FAP, AAFCO, novel foods ... is to engage multidisciplinary teams of science, engineering, and regulatory experts to empower clients with solutions that create...Offices globally Our Opportunity We are currently seeking a Senior Food Scientist for a Senior… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- …will be essential *Interact with scientists, medical directors, and Technical Operations / Regulatory Affairs personnel for the timely completion of clinical ... our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and...will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to… more
- Bio-Rad Laboratories, Inc. (Hercules, CA)
- As a Senior Staff Scientist . you`ll be right at the forefront of Bio-Rad's Clinical Diagnostics R&D Group - leading the design and validation of clinical ... coordination and execution of design validation studies in collaboration with clinical affairs , human factors, R&D, marketing and sales specialists to gather user… 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
- 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
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- The Senior Medical Area Scientist plays a crucial role in shaping the medical strategy for our organization. This position involves providing expert medical ... Scientist collaborates closely with cross-functional teams, including research, regulatory , and marketing, to ensure the successful development and launch of… 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
- 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
- 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
- J&J Family of Companies (San Diego, CA)
- …and analytic approaches in this setting + Engage with Clinical Development, Global Regulatory Affairs , Data Science & Digital Health, Patient Reported Outcomes, ... patients every step of the way. We are searching for a ** Senior Principal Scientist , Computational Multiomics, Precision Measures** , to be in either Cambridge,… more
- Colgate-Palmolive (Piscataway, NJ)
- …customers, including, Product Development, Consumer Affairs , Legal Department, Government Affairs , and Regulatory Affairs . + Representation of Colgate's ... with internal entities such as the Product Development, Legal and Regulatory departments as well as external groups including subsidiaries, trade associations… more
