- Battelle Memorial Institute (Columbus, OH)
- …critical services for our clients-whether they are a multi-national corporation, a small start - up or a government agency. We recognize and appreciate the value ... procedures are being followed. + Interprets and applies existing and new regulatory requirements and industry standards to operation methods and practices. Reviews… more
- Williams Companies (Houston, TX)
- …onshore and offshore installations + Identifies additional needs for facility design, start - up , operation, maintenance and integrity + Audits company facilities ... so bring your energy to ours. As a Senior Regulatory Compliance Specialist for Pipeline Control Governance, you will...(we promote from within) + Parental leave (we provide up to 6 weeks for each parent) + Fertility… more
- BeOne Medicines (Emeryville, CA)
- …submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and ... timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region...local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used… more
- Syner-G BioPharma Group (Boston, MA)
- …or systems for compliance with manufacturing requirements and facility fit.Lead start - up activities, including commissioning and qualification of facilities, ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- ValSource, Inc. (Rahway, NJ)
- …in the manufacturing field. Also responsible for activities related to the start - up , commissioning, qualification, validation of Pharmaceutical and Biotech GMP ... requirements to include but not be limited to: project installation and start - up activities, client meetings, company sponsored meetings, trainings. Proficiency… more
- Aequor (Basking Ridge, NJ)
- …study status on a regular basis. Review the initial supply needs for start - up , ongoing resupply strategy and amendments and closeout requirements. Address ... including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels. Ability… more
- Formation Bio (New York, NY)
- …GXP and CSV experienced team members. Track record of success in a biotech start - up or fast-paced, innovative, dynamic environment, with the ability to remain ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- BioAgilytix (Durham, NC)
- …designing Azure Data Factory and API integrations, automating data-quality checks, and setting up clear governance so everyone knows who can see or change each ... dataset. You'll start as a "player-coach," doing the technical heavy lifting...that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational… more
- Stony Brook University (Stony Brook, NY)
- …and timely reporting of patient results and compliance with all regulatory standards. Qualified candidates will demonstrate superior patient care and possess ... + Oversight of QA functions and monitors. Ensures staff compliance with all regulatory agency standards. Takes corrective action as needed. Insures the validity of… more
- Merck & Co. (Durham, NC)
- …raw materials, intermediates, and finished products.This role is within a capital project start - up in Durham, North Carolina. The new facility will include ... individual contributor production direct reportsSupports project team as operations leader through start - up , qualification through licensure, and ramp- up of… more
- BWX Technologies, Inc. (Oak Ridge, TN)
- …for building and overseeing the organization's EHS programs from the ground up , ensuring operational readiness, regulatory success, and a deeply embedded ... and Safety (EHS) to lead the development and execution of world-class regulatory compliance, safety, licensing, and quality programs for our advanced uranium… more
- Stony Brook University (Stony Brook, NY)
- …applications that referral laboratories use for test ordering, checking the NYS DOH regulatory status for the tests, following up on documentation, eg, consent, ... support of laboratory services. The position performs duties that include back- up supervisory, phlebotomy, quality assurance, send-out testing processing and billing… more
- Novo Nordisk Inc. (Boulder, CO)
- …equipment, instrumentation, and materials of construction to design, specify, procure, start - up , fully commission and troubleshoot equipment and systems required ... such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Analytical Development, Materials Management, and Clinical Supply Write,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …for clinical data acquisition, quality checking and reporting. + Focus on study- start up and database amendment implementation. + Study level coordination ... and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices...role manages trials in various stages, from planning, to start - up , conduct, closeout, and archiving. The role… more
- Insmed Incorporated (NJ)
- …working in a franchise with multiple brands preferredExperience working in a start - up and/or mid-cap sized company highly desiredOrphan or rare disease ... and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, and Commercial Operations… more
- Terumo Medical Corporation (Somerset, NJ)
- …final study reports. + Clinical operational activities: + Support trial study start - up phases (support in writing study protocol, identification of investigators ... the organization that includes Medical Affairs, Clinical Operations, Sales, Marketing, Regulatory Affairs, to ensure maximum exchange of information and insights.… more
- Battelle Memorial Institute (MA)
- …critical services for our clients-whether they are a multi-national corporation, a small start - up or a government agency. We recognize and appreciate the value ... account lead for clients requiring PFAS testing, method development, and regulatory compliance support. + Collaborate with technical teams to translate client… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance/ regulatory mandates and quality requirements. Complying with company policies and ... and Safety: All employees must undergo various training activities at the start of their employment. New training and re-trainings will occur periodically.Employees… more
- AUROBINDO (Dayton, OH)
- …support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
