- Cleveland Clinic (Cleveland, OH)
- …+ Assist with wide variety of patient care tasks and collaborates with members of health care team to promote the delivery of patient care. + Organizes patient care ... assignments to ensure timely delivery and completion of care on assigned patients. + Seeks assistance as necessary for difficult assignments or problem solving. + Documents the care provided in patient record. + Labels specimens properly. + Asks patient about… more
- Cleveland Clinic (Cleveland, OH)
- …+ Responsible for transporting visitors and patients via wheelchair, cart or bed. + Practices injury prevention. + Ensures safety of self and patient when ... The Nursing Department Assistant II (NDAII ) is responsible for providing for patients' activities of daily living; maintaining a safe and clean environment; maintaining established levels of supplies; maintaining proper equipment function; and transportation… more
- Sumitomo Pharma (Columbus, OH)
- …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
- Bausch + Lomb (Columbus, OH)
- …development and acquisitions. + Lead all CMC regulatory activities for IND, NDA , ANDA, and BLA submissions. + Plan, author, review, and coordinate high-quality ... as PAS, group supplements, site transfers, and supplier changes) for IND, NDA , ANDAs and amendments/supplements. + Serve as RA representative on facility/site Local… more
- Bausch + Lomb (Columbus, OH)
- …labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements + Plan, ... as PAS, group supplements, site transfers, and supplier changes) for IND, NDA , ANDA amendments/supplements + Review raw materials and formulations, provide advice to… more
- J&J Family of Companies (Cincinnati, OH)
- …of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/ NDA and/or their global counterparts) is _preferred_ . + May require up ... to 15% domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national… more
- Ohio Machinery Co (Perrysburg, OH)
- …repair general heavy equipment drive-train components, electrical and hydraulic systems , a nd sta nda rd machine repair s . You will work from an Ohio CAT service ... truck in the natural elements. COMPETENCIES: + General technical service skills, mechanical aptitude, or experience with construction or heavy equipment , an d strong DC electrical and machine electronic systems knowledge are r eq ui red . + Must demonstrate… more
- Sumaria Systems, Inc. (Fairborn, OH)
- …to AFLCMC/WII Division Contracting Officer authorization and review of a signed NDA , the employee shall provide advisory and draft documentation support in source ... selections to include Acquisition Strategy Plan (ASP) development and Instruction to Offerors (ITO), and Sections L and M development. The employee shall assist in researching and updating government-approved financial data in systems including Mechanization… more
- Parexel (Columbus, OH)
- …applications in eCTD format * Respond to Health Authority questions during IND/ NDA review phases * Review and approve technical documents across Clinical, ... Nonclinical, and CMC domains * Monitor evolving regulations and translate changes into internal SOPs and process improvements * Collaborate with Regulatory Operations to ensure eCTD compliance and submission readiness * Support international trials through… more
- Parexel (Columbus, OH)
- …in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA , DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and ... regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! Skills & Attributes * Strategic and proactive mindset with strong operational execution * Excellent analytical, problem-solving, and… more