- ASRC Industrial Services (Oak Ridge, TN)
- NDA Analyst - Engineer - Oak Ridge, TN Summary **Title:** NDA Analyst - Engineer - Oak Ridge, TN **ID:** 2252 - RSI - 02 Description _ASRC Industrial and its ... **Position Summary** RSI is actively seeking a Nondestructive Assay ( NDA ) Professional to support the NDA Program...Nondestructive Assay ( NDA ) Professional to support the NDA Program for the UCOR Cleanup Projects at Heritage… more
- Cleveland Clinic (Cleveland, OH)
- …on January 29, 2026, for full-time and part-time Nursing Department Assistant ( NDA ) roles.** As a Nursing Department Assistant, you will provide support with ... patient daily living activities and room maintenance alongside your fellow caregivers. In this role, you will also assist with various related tasks, such as performing EKGs, monitoring blood glucose levels, collecting specimens, documenting vital signs and… more
- Cleveland Clinic (Cleveland, OH)
- …for the ideal future caregiver include: + High School Diploma/GED + Basic Life Support (BLS) Certification through the American Heart Association (AHA) within new ... hire period + Basic math skills and ability to read and write Preferred qualifications for the ideal future caregiver include: + State Tested Nursing Assistant (STNA) Certification + Previous nursing assistant experience Our caregivers continue to create the… more
- Cleveland Clinic (Cleveland, OH)
- …for the ideal future caregiver include: + High School Diploma/GED + Basic Life Support (BLS) Certification through the American Heart Association (AHA) or American ... Join Cleveland Clinic's Lutheran Hospital where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Lutheran Hospital's Magnet status, the highest international recognition for excellence in… more
- Western Digital (Irvine, CA)
- …Western Digital's innovative technology and strategic partnerships through skilled NDA administration. This individual will also support attorneys and contract ... policies. + Escalating issues with NDAs to appropriate stakeholders. + Supporting NDA playbook updates or modifications and work to create and coordinate efficient… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …regulatory strategies for late-stage development, marketing applications (eg, NDA /MAA), and post-approval lifecycle activities (supplements, renewals, variations) ... Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/ NDA /MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical… more
- Capgemini (New York, NY)
- …pharma and biotech clients, leading engagements on **submission readiness (IND/ NDA /BLA/MAA)** , **regulatory strategy** , **eCTD compilation/automation** , **CDISC ... . **Key Focus Areas** + **Regulatory Submissions & Strategy** : IND/ NDA /BLA/MAA pathways (traditional, 505(b)(2), accelerated, breakthrough). + **eCTD & CTD… more
- Sumitomo Pharma (Montgomery, AL)
- …in Oncology. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual ... all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as… more
- Butler America (Washington, DC)
- …work. + Familiarity with and ability to work with SharePoint based tools for NDA request and approval workflow and NDA repository management. + May provide ... advice and guidance to internal stakeholders relative to acceptability of certain simple NDA provisions and make recommendations to IP legal, as may be required. +… more
- Taiho Oncology (Princeton, NJ)
- …regulatory integrity and completeness of all projects, supporting IND, CTA, NDA , MAA submissions. Performance Objectives: + Manage and support the preparation, ... submissions as assigned, including INDs and amendments, CTAs, marketing applications ( NDA /MAA), annual reports, safety reports, etc. + Support planning and executing… more
- AbbVie (Jersey City, NJ)
- …all patient safety activities, and will be leading the safety components of pre- NDA and NDA /sNDA submissions, regulatory responses, label and label updates, ... limited to, medical safety assessments, regulatory responses and risk management plans, NDA /sNDA submission - safety component + Apply current regulatory guidance as… more
- City of New York (New York, NY)
- …low-income communities it designates as Neighborhood Development Areas (NDAs). The NDA Initiative fosters community-level engagement to ensure that services address ... of each community. DYCD is seeking a Deputy Director to help lead its NDA Initiative portfolio. Under the supervision of the Director, with wide latitude for… more
- Stryker (Springfield, IL)
- …support drug development both domestically and internationally.Regulatory pathways may include INDs, NDA or sNDA, DINAs, etc. + Provides regulatory guidance to and ... + 5 years of managerial experience preferred + Experience with successful NDA and DINAs. Prefer additional experience with IDEs/ 510(k)s and/or combination products.… more
- Bristol Myers Squibb (Princeton, NJ)
- …research and drug development, including global regulatory submissions (IND/CTA through NDA /BLA/MAA/JNDA/ NDA China) and lifecycle management. + Proven success ... as a PM delivering programs teams with high level of enterprise visibility. Long-standing experience which demonstrates strong matrix leadership abilities. + Excellent written and verbal skills, (including full professional English proficiency). + Must be… more
- Adecco US, Inc. (Morristown, NJ)
- …and global escalations. * assists in review of medical compendia and contributes to NDA annual reports. * provides summaries of literature searches for NDA ... product annual reports for FDA submissions. * interacts with contact center team(s) and coordinates meetings, trainings and exchange as needed * performs regular contact center quality checks in US * supports training of support function staff and outsourced… more
- Robert Half Accountemps (Buffalo, NY)
- …Manager (training provided if needed). Handle sensitive information with discretion; NDA may be required. Provide occasional office support and field incoming ... Manager (training provided if needed). Handle sensitive information with discretion; NDA may be required. Provide occasional office support and field incoming… more
- Lilly (Indianapolis, IN)
- …Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries. + Author and ... + Proven success track in advancing parenteral products from clinical to BLA/ NDA regulatory submission is highly preferred. + Demonstrated ability to influence… more
- University of Utah (Salt Lake City, UT)
- …PET ) radiopharmaceuticals while complying with radiation safety procedures, cGMP and NDA / IND requirements. This includes oversight of the operation, maintenance ... regulatory writing and submissions including CMC sections, DMF , IND , and NDA / ANDA . + Previous experience in radiopharmaceutical research and grant submission.… more
- IQVIA (Durham, NC)
- …+ Contribute to clinical study reports and other regulatory documents, eg NDA , DSURs, Briefing Documents, ISS, ISE, etc. + Provide guidance and supervision ... for accuracy. + Support exploratory analyses. + Participate in pre-IND or NDA activities. + Participates in other activities and meetings to support Biostatistics… more
- BeOne Medicines (Emeryville, CA)
- …expertise with advanced project management skills, driving successful NDA /BLA/MAA submissions and ensuring cross-functional integration across regions. The ... Management Excellence** + Lead and manage complex regulatory submissions (IND/CTA, NDA /BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China,… more