- Formation Bio (New York, NY)
- …quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and company policies. Establish and ... regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines. Proven experience in developing,… more
- Formation Bio (New York, NY)
- …teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key ... regulatory meetings (eg, FDA , EMA) to ensure statistical rigor in clinical development...regulatory agencies. Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (eg, East, PASS, NQuery).… more
- Lundbeck (Greensboro, NC)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Formation Bio (New York, NY)
- …regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines. Demonstrated experience with batch ... at all levels of the organization. Experience leading regulatory inspections (eg, FDA inspections, MHRA inspections, EMA inspections, etc. ) and customer audits,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …switches and databases. Job Responsibilities:Perform system administration (access control, software revision control, back-up and recovery), and troubleshooting for ... new systemsResponsible for reviewing functional specifications for both hardware and software for new automated utility, process, filling, and packaging and… more
- Lundbeck (College Station, TX)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... communication skills Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Merck & Co. (Rahway, NJ)
- …research and clinical trial methodologies.Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH guidelines.Excellent strategic planning and execution ... demonstrable experience in a people management role.Expertise in Prelude software or similar dedicated data management applications.Comprehensive understanding of… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical QC laboratory Assist with implementation and integration LIMS and other Novo software systems as they relate to Quality Control Create and refine process ... with a willingness to learn new IT applications Demonstrated knowledge of US FDA , ICH Q7, & ISO regulations, guidelines, and applications of cGMP's within Quality… more
- Lundbeck (Oakland, CA)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... customer influence network Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Tris Pharma (Monmouth Junction, NJ)
- …statistical and regulatory standardsPerforms statistical analyses using advanced methods and software (ie, SAS, R, etc.); Interprets and reports results of ... strategy discussions in cross functional settingsExperience interacting with the FDA and other regulatory organizationsHands-on experience with statistical design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sourcing, Inventory Control and Shipping/Receiving. Ensures that systems and software [SAP: Material Requirements Planning (MRP), Purchase Order Management, ... planning and/or materials management preferred1 or More Years of knowledge of FDA requirements preferredAbility to travel up to 20% Primary travel to domestic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... projects with external vendors and internal IT teams towards building software tools. Essential Functions Understands internal stakeholder needs and translates those… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry.Proficient computer skills to be able to navigate specialized software and databases.An ability to build strong partnerships and effectively ... to detail and the ability to follow procedures.Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.Ability to lift a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational ... Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of multi-tenant, cloud-based architectures. A background with Class I or Class II FDA software medical devices is desirable, as the Pyxis products span ... us. We are seeking highly motivated, self-directed, and experienced in software development for **cloud-based applications (AWS, Azure, GPC, etc.)** and… more
- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... products that meet budgetary objectives. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. + Lead … more
- Bio-Techne (Wallingford, CT)
- …medical devices; knowledge of standards: GAMP 5, FDA GMP + Experience with FDA regulations for software validation and 21CFR compliance + Ensure that all ... new insight into proteins and their role in disease. Software is vital to our success in developing award...an opportunity to work with state of the art software /hardware technologies amongst a very creative, motivated, and talented… more
- Edwards Lifesciences (Naperville, IL)
- …to work independently and proactively in a fast-paced environment. + Prefer experience with FDA guidelines for Software Quality and Systems Validation is a plus ... collaboration with the Sustaining Engineer and Product Owner, this position provides technical/ software expertise to the product team. This position works on both… more
- Abbott (San Diego, CA)
- …Follow approved design control procedures for product development in accordance with FDA guidelines + Direct the software engineering group, providing mentoring, ... mothers, female executives, and scientists **The Opportunity** Directs the software engineering function in developing, releasing, and maintaining PC application… more
- Abbott (Columbus, OH)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Experienced in ... the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with...concerns in a timely manner + Comply to all FDA policies and standards + Use M-Files to house… more
