- 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
- 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
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …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
- 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
- Sumitomo Pharma (Columbus, OH)
- …(Stage 1,2, and 3) that supports phase appropriate development programs, NDA /BLA enabling validation programs and ongoing commercial manufacturing activities. + ... validation and transportation qualification/validation. + Plan, Design and execute major NDA /MAA enabling projects through sound DOE, early risk assessments and… more
- Alaka'ina Foundation Family of Companies (Dayton, OH)
- …reporting systems. + Must be willing to sign a Non-Disclosure Agreement ( NDA ) DESIRED SKILLS AND EXPERIENCE: + Experience using Air Force accounting Comprehensive ... Cost and Requirement System. + Demonstrated experience working in a STEM (science, technology, engineering, and math) or Research & Development work environment. + DoD Financial Manager and/or Comptroller professional training and certification. REQUIRED… more
- Oracle (Columbus, OH)
- …ABB, Vertiv, Cummins, MTU). + Vendor model acquisition/validation under NDA ; understanding of licensing/IP. Disclaimer: **Certain US customer or client-facing ... roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $97,500 to… more
- Eaton Corporation (Cleveland, OH)
- …strategic operational initiatives such as organizational redesign, contractual management from NDA to Global MSA, lead management, digital literacy, data accuracy, ... forecast management and growth initiatives. + Act as SME and BPO for cross-functional CRM use, adoption, data quality, and reporting. + Collaborate with executives and regional leaders to standardize work processes, optimize productivity, and implement growth… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …a strong working knowledge of applicable US regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and ... with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral ... and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. -… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …assigned and for the successful implementation and completion of trials leading to NDA , BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical ... development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design,… 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
