- Merck & Co. (Upper Gwynedd, PA)
- …risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory ... are a plus.Preferred Experience and Skills: The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical… more
- Eisai, Inc (Exton, PA)
- …suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite ... groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related ... the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for… more
- Eisai, Inc (Nutley, NJ)
- …with creating, updating and maintaining project trackers in EPICProvides support for document preparation and follow-up (eg Informed Consent Form, eTMF fling ... action Item follow-upAttends CRO and vendor teleconferences as applicableReview regulatory packet for investigational product releaseProvide user access management… more
- University of Iowa Hospitals & Clinics (Iowa City, IA)
- …maintenance of documents. Maintain regulatory files and binders. Responsible for regulatory process and document preparation used in the implementation ... 6 months - 1 year of related experience with preparation of IRB submissions or regulatory submissions with clinical trials is required. Excellent written and… more
- Dyne Therapeutics (Waltham, MA)
- …guidelines Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation ... Summary: The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This… more
- Revival Research Institute, LLC (Evans, GA)
- …study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation , with oversight eg study amendments, ... adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's… more
- Globus Medical (Audubon, PA)
- …other Clinical Affairs personnel, as needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... can resume their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for 510(k)… more
- HOLLY HALL (Houston, TX)
- …food functions in accordance with current applicable federal, state, and local regulatory guidelines. Duties and Responsibilities : Review menus prior to serving ... is served to the resident. Assist cooks in meal preparation including salads, fruits, and desserts. Follow department standard...of special diets in accordance with State and ADA regulatory guidelines. One (1) year food experience in a… more
- StateJobsNY (New York, NY)
- …with customer agency guidelines, applicable codes, reference standards and other regulatory requirements. The Design Manager may also provide design review and ... Perform plan review assignments at various stages of design to ensure project document compliance with all applicable client, state and federal codes, laws, rules,… more
- BankUnited (Dallas, TX)
- …from other banking personnel and transactional testing. This position will require preparation of Suspicious Activity Reports or other regulatory reports to ... is warranted. Conduct in-depth research into customer accounts, properly document findings and communicate with account officers requesting information to… more
- Sharp HealthCare (La Mesa, CA)
- …position requires the ability to combine clinical/quality considerations with regulatory /financial/utilization review demands to assure patients are receiving care ... level of care. The RN CM will recommend and document patient classification (status and level of care) for...RN CM has accountability for maintaining compliance contractual and regulatory compliance with medical groups as applicable and the… more
- Stantec (Plano, TX)
- …pin-ups. Interpret and apply building codes and requirements of other regulatory agencies. Prepare and revise documentation in various architectural phases including ... meetings and value analysis and basic cost estimating. Assist in the preparation of the project specifications. Coordination of specs with construction documents.… more
- King County, WA (Seattle, WA)
- …within the Grants Compliance team. The team is responsible for the preparation of countywide reporting of Federal and State grants, compliance monitoring, ... to agencies for federal and state grants financial reporting through review and preparation of reporting and support documents. Prepare high volume of quarterly and… more
- Children's National Hospital (Silver Spring, MD)
- …with corporate or operational healthcare experience handles corporate transactions and regulatory matters to assist in managing contract reviews for the entire ... form of agreements, and has knowledge about various federal and state regulatory requirements (eg HIPAA, fraud and abuse, Stark analysis), the contract management… more
- Danbury Hospital (Danbury, CT)
- …with all hospital and networks policies. d. Demonstrates ability to accurately document any necessary regulatory documentation. e. Identifies patterns of ... Hospital Summary: Performs all functions needed to ensure proper storage, preparation and dispensing of medications. Interpret and evaluate physician orders for… more
- Rivian (Irvine, CA)
- …of supporting the Attribute target definition. DVP creation, test planning, vehicle preparation , vehicle testing, data analysis and documentation are part of the ... Analyze and present results to leadership and cross functional teammates. Identify, document , and highlight system design gaps and vehicle issues during all phases… more
- TD Bank Group (Mount Laurel, NJ)
- …& Analytics, etc.) May also be responsible for developing sophisticated data preparation frameworks and architecture to create or modify data features for ... and timelines Lead status reporting - escalate delays in meeting timelines, document milestones achieved for Sr. Executives Coordinate input to executive reporting… more
- MLee Healthcare Staffing and Recruiting, Inc (Oakland, CA)
- …Support specimen collection and prepare samples for testing as required. Document all laboratory procedures meticulously, train newcomers or interns, and uphold ... standards. Maintain a safe and clean working environment while following regulatory and accreditation guidelines. Education Bachelor's degree in Clinical or Medical… more
- Goldrich Kest (West Covina, CA)
- …issues. Analyze financial reports, vacancy turn around reports, and participate in the preparation of annual budgets. Follow up and document discrepancy found in ... and approve all A/P in a timely manner. Monitor expenses to budget, utility expense, preparation of move out statements are completed within 21 days of move out, and… more
