- Spectraforce Technologies Inc (Athens, GA)
- Job Title: Specialist , US Regulatory Affairs Operations (Part-Time) Duration: 18 Months Location: St. Joseph, MO or Athens, GA Schedule: 20 hours per week; ... 2-3 days a week. Duties: With minimum guidance, prepare high-quality US regulatory submissions required by local and federal agencies to maintain Company products… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Training Operations Associate Specialist will be an energetic individual with strong ... Job DescriptionOur Manufacturing Operations teams are the people that make our...manufacturing and related systems (ie SAP) Familiarity with pharmaceutical regulatory requirements Project management and data analysis skillsTechnical writing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist , Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors,… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be responsible for ... point of contact for budget development responsibilities.Support Global Clinical Trial Operations with budget process expertise and study specific support to ensure… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (Rahway, NJ)
- …CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other ... implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines.- Assisting with...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Millsboro, DE)
- …tests, and review and release of antigen and seed batches. The QC associate specialist must adhere to regulatory and site policies and procedures governing the ... in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. ... Overview We are actively seeking a proficient SAP Master Data Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End Manufacturing… more
- Merck & Co. (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... data governance reviewsThe Global Clinical Data Standards (GCDS) Data Standards Specialist may contribute to the definition and maintenance of business processes… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... work with constituent groups include but not limited to internal customers ( operations , technology and labs)Applies understanding and is able to anticipate the needs… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations ; providing multiple opportunities to learn new automatioThe Specialist is a member of the Focus Factory Automation team responsible for ... Job DescriptionPosition Description: Specialist , Manufacturing Automation (Hybrid) g, quality and engineering...the assigned process control systems in support of manufacturing operations located in Durham, NC.As an Automation Engineer, you… more
- Merck & Co. (Durham, NC)
- …to plant maintenance and spare parts procurement systems. Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Ability to ... Job DescriptionOur Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics --Immune/Oncology-(QP2-IO)-team in the role of-Senior Specialist .--QP2-IO team is part of the Global Clinical Development ... senior scientists you will develop a comprehensive understanding of global regulatory expectations for small molecules and biologics, including support and authoring… more
- BioAgilytix (Durham, NC)
- …data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the ... quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell...review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (eg GLP,… more
- Eisai, Inc (Nutley, NJ)
- …mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who ... policies and guidelines; apply these standards across all business operations (ie policies/procedures, resource utilization, sales and account data, etc.)Cultivate… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- BioAgilytix (Durham, NC)
- …including liquid handlers, robotic arms, and automated assay platforms.Familiarity with regulatory requirements for laboratory operations , including GLP and ... therapeutics to the patients who need them.The Senior Laboratory Automation Specialist will be primarily responsible for leading the programming and implementation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to be part of the team responsible for Warehouse activities that will… more
- Mindlance (Charlotte, NC)
- Job Title: Regulatory Specialist (FR Y-14Q) Location: NY, NJ, MN, TX, NC, AZ, CA (3 days onsite, 2 days remote) Duration: 12+ months Required Qualifications: 7+ ... Lead Business Execution Consultant, as part of the Finance & Risk Regulatory reporting function within the Commercial Banking. Candidates will be interested in… more
