- 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
- Integrated Resources, Inc. (Princeton, NJ)
- …*3+ years' in medical writing for the pharmaceutical industry, with a focus on regulatory document preparation ; knowledge of drug development process and ... and international regulations, requirements and guidance associated with scientific and clinical/ regulatory document preparation and submissions. Knowledge… more
- Thomas Jefferson University Hospitals, Inc. (Philadelphia, PA)
- …data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation . Ensuring all study ... staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups. Job Description Essential Functions:… more
- U-Haul (Phoenix, AZ)
- …Key Responsibilities: Regulatory Filings & Compliance Support Assist in the preparation and submission of Med Supp rate filings with state regulators. Monitor ... 2721 N Central Ave, Phoenix, Arizona 85036 United States of America he Regulatory Compliance Analyst supports the Compliance, Actuarial, and Finance teams in the… more
- Corcept Therapeutics (Redwood City, CA)
- …requests, briefing books, annual reports/development safety update reports (DSURs) Oversee document preparation activities and track progress against targets; ... will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is a hybrid… more
- DermBiont (Emeryville, CA)
- …standards. Assist cross-functional teams on interpretation of policies, guidelines, and regulatory requirements to support regulatory document production. ... drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management… more
- CHS Inc (Inver Grove Heights, MN)
- …preparation and evaluation of stability/compatibility under Chemist guidance. Document findings and prepare clear, concise technical reports. Communicate ... including HPLC, ICP (eg, ICP-MS/OES), and GC systems. Perform sample preparation and analysis using HPLC/ICP, following standard methods; troubleshoot minor issues… more
- Thermo Fisher Scientific (West Hills, CA)
- …procedures and/or work instructions Show initiative and ownership with assisting in document preparation /presentation for regulatory agency visits and ... Corporate/internal audits Provide real-time support to Product Packaging and Labeling to prevent backorders, non-conforming materials release and adherence to the production schedule Maintain quality, compliance, and safety following laws, policies, and… more
- Pennsylvania Medicine (Lancaster, PA)
- …with the patients regarding co-pays, out of pocket expenses, pre-appointment preparation , arrival times, etc. Verifies patient, guarantor, coverage and hospital ... information that is documented on paper. Sends all pertinent information to document imaging or heath information management team with in the established time… more
- Florence Copper (Florence, AZ)
- …CAD/GIS Operator is responsible for creating technical drawings and maintaining document control processes for engineering, safety, and regulatory documentation ... drawings and GIS maps of wellfield plans, site infrastructure, as well as preparation of schematics, figures, and maps for public affairs, safety and other… more
- Clinical Dynamix, Inc. (Boston, MA)
- …and assays for Anti-Drug Antibody (ADA) assessment Ensure compliance with regulatory requirements and industry standards for translational and clinical pharmacology ... validity and interpretation of non-clinical data to support clinical programs and regulatory applications Author and review PK, TK, PD, ADA and associated… more
- OTTAWA UNIVERSITY (Leawood, KS)
- …the main liaison between the University and the Kansas Behavioral Sciences Regulatory Board (BSRB). Participate in and occasionally lead New Counseling Student ... of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or...in the state of Kansas with professional or academic preparation in one or more areas of concentrations including:… more
- Your Company Name (New York, NY)
- …other reference materials to gather relevant information for cases and projects. Document Preparation : Prepare and format legal documents, including briefs, ... in the smooth operation of our legal proceedings and ensuring adherence to regulatory requirements. This role offers an exciting opportunity to contribute to various… more
- DeKalb County (Decatur, GA)
- …field required; five years of experience in building design, construction document preparation , plan review, code analysis, building inspections, construction, ... and materials. Provides quality customer service while functioning in a regulatory capacity. Provides coordination with Permit Manager, Fire Marshal Office,… more
- The University of Kansas Health System (Kansas City, MO)
- …completing the Medicare Secondary Payer Questionnaire (MSPQ), scanning and document preparation , updating documentation and processing of ... up-to-date and accurately entered in the correct location. Follows all regulatory and compliance standards. Follows documented protocols and guidelines. Responds to… more
- Pacific Gas and Electric Company (Oakland, CA)
- …proceedings, processes, and procedures Experience with federal, state, and local regulatory and commission case management Experience with document management ... legal activities fall into the following categories: Litigation, Employment, Regulatory , Strategy and Policy, Commercial Contract, and Corporate Services. Position… more
- USAA (Northborough, MA)
- …supervising attorney. This includes but is not limited to research, contract administration, document preparation , and trial preparation . The legal work ... documents. Applies proficient knowledge to properly file documents with regulatory authorities, courts, other tribunals, and monitors status. Prepares presentations… more
