- Unilever (Trumbull, CT)
- …for innovation and ensures ongoing compliance. + Works closely with the PC North America Regulatory Affairs team to execute the short and long term regulatory ... innovation and compliance. + Works closely with local and global PC Regulatory Affairs team, Safety, Environmental & Regulatory Science (SERS), CTI,… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- 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
- Veterans Affairs, Veterans Health Administration (Oklahoma City, OK)
- Summary The Supervisory Clinical Laboratory Scientist (Laboratory Manager) must spend a quarter or more of their time providing administrative and technical ... Total Rewards of a Allied Health Professional Required to know regulatory , licensing, accrediting agency requirements and statutes governing clinical laboratory… more
- Kerry (Clark, NJ)
- …Science, or a related field. Minimum of 5 years of experience in food/flavor regulatory affairs or a related field. Strong working knowledge of FDA/USDA ... environment. About the role As part of Kerrys North America Taste Regulatory Scientific Affairs team, this role will provide regulatory and technical… 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
- AbbVie (North Chicago, IL)
- …programs developed internally, partnering closely with Drug Substance, Drug Product, Regulatory Affairs , QA and Process Development Sciences & Technology. ... analytical sections of IND/IMPD filings and contribute to global regulatory strategy alongside Reg Affairs . + Collaborate...degree with 8 years of experience. + Qualification for Senior Scientist I: Ph.D. with 0-4 years… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- 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
- Abbott (Santa Clara, CA)
- …holders including clinical project management, clinical operations, biostatistics data management, regulatory affairs , medical affairs , and external stake ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Senior Clinical Scientist ** **Working at Abbott** At Abbott, you can do… 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
- 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
- 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
- Boehringer Ingelheim (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
- HNTB (Boston, MA)
- …protocols to ensure compliance with design criteria, scientific specifications, and regulatory approvals/permits. + Serves as senior reviewer of technical ... for local, state, and federal environmental permits as well as other regulatory compliance laws and regulations. + Organizes and participates in public meetings.… more
- AbbVie (North Chicago, IL)
- …engineers, pilot plant engineers, drug product development scientists, program managers, and regulatory affairs specialists. + Author publications and present at ... chain for pipeline molecules and help prepare and defend CMC regulatory content. Chemical/Bio Engineers within Process Engineering support pipeline projects through… more
- Bristol Myers Squibb (Cambridge, MA)
- …the PC space + Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external ... after clinical proof-of-concept studies, including but not limited to regulatory submissions and life-cycle management. Translational disease strategies in… more
- Lilly (Indianapolis, IN)
- …BU Medical, other MDU Functions, Clinical Development (early and late phase), Regulatory Affairs - North America and International, regional/affiliate brand ... for people around the world. **Sr. Director / Executive Director - Safety Data Scientist ** **Purpose:** The purpose of the Sr. Director / Executive Director - Safety… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …& Data Science, Hardware Engineering, Process Engineering, and Quality & Regulatory Affairs (QA/RA). Primary responsibilities focus on making fundamental ... healthcare and improving patient outcomes. We are seeking a Senior Product Development Scientist to join the...critical protocols and studies related to V&V for 510(k) regulatory submissions + Read, comprehend, and implement best practices… more
- Astellas Pharma (Northbrook, IL)
- …interested in remote work are encouraged to apply. **Purpose and Scope:** The Statistical Scientist Lead in the Innovative Statistical Science group is a senior ... statistical science internally and externally, develop a reliable network of academics, regulatory experts, and industry peers, and lead the research area as an… more
- Merck (Rahway, NJ)
- **Job Description** **Role Summary** + Under the guidance of a senior leader, a Senior Principal Scientist / Senior Director, has primary responsibility ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
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