- Twist BioScience (South San Francisco, CA)
- …GCP) and DevOps practices.Direct experience participating in regulatory audits (eg, FDA inspections) specifically related to custom software and CSV.Experience ... Director will lead a team of MES professionals, primarily software developers, who work in concert with Manufacturing Operations,...MES solutions comply with GxP regulations (eg, cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and… more
- Merck & Co. (Rahway, NJ)
- …PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( ... FDA , EMA, PMDA),Guiding project teams preparing submission deliverables including...Experience: Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Experience assuring consistency across protocols and… more
- Lundbeck (Fort Wayne, IN)
- …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… more
- Merck & Co. (Rahway, NJ)
- …(Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for ... cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews and resolves issues that… more
- Lundbeck (Joliet, IL)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... communication skills Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Formation Bio (New York, NY)
- …high-value negotiations with vendors across multiple categories, including software , contract research organizations (CROs), contract manufacturing organizations ... and monitor vendor compliance with company policies, industry regulations (eg, FDA , EMA, GxP), and data security requirements. Identify opportunities for cost… more
- Insmed Incorporated (San Diego, CA)
- …and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy, ... and maintains detailed records. Analyzing data, preparing reports, and using statistical software for trend analysis are also key duties. Collaboration with R&D,… more
- Merck & Co. (Rahway, NJ)
- …options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong experience ... Pharmaceutical Microbiology, Pharmaceutical Sciences, Pharmacokinetics, Product Development, Regulatory CMC, Software Development {+ 3 more}-Preferred Skills:Job Posting End Date:08/22/2025… more
- Eisai, Inc (Nutley, NJ)
- …to 2 years of relevant experience.Prior understanding and knowledge of FDA guidances on appropriate scientific exchange practices.Demonstrated experience in medical ... professional relationships with key stakeholders.Experience with Microsoft Office Suite software , SharePoint, Veeva, customer relationship management software … more
- Formation Bio (New York, NY)
- …with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for clinical trial endpoints Build scalable infrastructure for processing and ... analysis, including hands-on experience with DICOM standards and medical imaging software Strong programming skills in Python with expertise in PyTorch/TensorFlow… more
- Aequor (Hicksville, OH)
- …policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.) Note: This position may require the labeling, ... be able to identify and recommend improvements. Ability to learn and apply new software multimedia applications Ability to lift up to 50 lbs. Ability to stand for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …management experience a plus Knowledge, Skills, and Abilities Knowledge of Cgmp's, ISO and FDA requirements a plus Able to develop and manage action plans to achieve ... of computerized inventory and MRP systems, word processing and spreadsheet/database software required We commit to an inclusive recruitment process and equality… 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 ... detail and the ability to follow procedures.Knowledge of cGMP regulations and FDA guidance related to manufacturing cell-based products.Ability to lift a minimum of… 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
- Aequor (Thousand Oaks, CA)
- …Ensure all data management activities comply with regulatory standards (eg, FDA , EMA, ICH-GCP). Cross-Functional Collaboration: Collaborate with clinical teams to ... of data visualization tools (eg, Tableau, Power BI). Knowledge in statistical software (eg, SAS, R) for data analysis. Knowledge, and ideally experience, of… more
- Eisai, Inc (Nutley, NJ)
- …experience are required.Experience with programming methodologies, best practices, software applications development/support in the pharmaceutical or related ... SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.Strong organizational skills with… more
- Genmab (NJ)
- …non-comprehensive list of deliverables: IB, DSUR, briefing packages for FDA , EMA etc., supplementary in-house preparations for DMC-meetings, RP2D- selection ... represent programming in teams and meetingsHas experience with the SAS software packageMinimum BSc. or equivalent qualificationsHas experience working in a global… more
- AbbVie (Pleasanton, CA)
- …with preferably no managerial intervention. Qualifications *BS in Mechanical, Software , Electrical Engineering or equivalent degree. Advanced degree desirable. *Must ... Additional Requirements: *Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device… more
- Abbott (San Diego, CA)
- …instruments and software required. Experience with meeting global (ie, US FDA , IVDR, PMDA) cybersecurity, EMC, and software requirements. Regulatory history, ... identified, obtained, and effectively presented for product registration worldwide (US, FDA , CE-IVDR, PMDA, etc.). Strategic Planning: Identify and approve new… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …documents for submission to the US Food and Drug Administration ( FDA ). This position provides advice and direction regarding regulatory requirements. Qualifications ... inspections to ensure appropriate information is supplied as requested. Accompanies FDA inspectors for pre-scheduled new and routine center audits as directed.… more
