- GRAIL (Annapolis, MD)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
- Parexel (Annapolis, MD)
- …regulations. + Broad experience in preparation of all types of clinical regulatory documentation . Experience in management of complex medical writing projects. ... The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales… more
- Parexel (Annapolis, MD)
- **Job Summary:** The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- Parexel (Annapolis, MD)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... reports required information to resolution + Submit all required reports, documentation , updates and tracking within required timeframes, including but not limited… more
- Johns Hopkins University (Baltimore, MD)
- …Manages multiple complex internal audit projects. Manages and serves as a technical expert to internal audit staff. Partners with department leadership: Chief Audit ... systems, web-based and other information sources Utilize organizational and regulatory knowledge to identify audit constraints and shape priorities. Negotiate… more
- Johns Hopkins University (Baltimore, MD)
- …with the institution's evolving operating model for administrative services, regulatory obligations, and Workday implementation. The Sr. Strategic Advisor serves ... a knowledgeable liaison between the project's diverse communities- functional, technical , and change management oriented. Specific Duties & Responsibilities Policy… more
- Johns Hopkins University (Baltimore, MD)
- …clinical or academic/research department. Additionally, since this position serves as the senior financial and operations officer for the Johns Hopkins Center for ... audits, and investigations of international financial irregularities. Collaborate with Technical Programs, HR, Business Development, and PR and Communications units… more
- Johns Hopkins University (Columbia, MD)
- …Operational Oversight - Intermediate Oral and Written Communications - Intermediate Regulatory Compliance - Intermediate The core technical skills listed ... Oversee the procurement process for all assigned accounts. Provide back-up documentation and explanation in response to audit requests. Prepare financial projections… more
- Johns Hopkins University (Baltimore, MD)
- …with more complex grant management under the direction and oversight of a more senior member of the team. Types of sponsored awards for which the position is ... May work with representatives from ORA, under the guidance of more senior members on the departmental research team. Understand and utilize institutional policies… more
- Johns Hopkins University (Baltimore, MD)
- …systems. Specific Duties & Responsibilities Assist Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol/study ... equivalency formula. Preferred Qualifications Master's Degree in a related field. Technical Skills and Expected Level of Proficiency Budget Management - Developing… more
- Johns Hopkins University (Baltimore, MD)
- …benefit rates for proposed budgets. Prepare and present budget proposals to senior management. Create financial systems, structures, and controls for a variety of ... and/or format data and/or reports. Other duties as assigned. Technical Qualifications & Specialized Certifications Strong analytical and modeling capabilities,… more
- Johns Hopkins University (Baltimore, MD)
- …benefit rates for proposed budgets. Prepare and present budget proposals to senior management. Create financial systems, structures, and controls for a variety of ... the extentpermitted by the JHU equivalency formula. Preferred Qualifications Technical Qualifications & Specialized Certifications Strong analytical and modeling… more
- Johns Hopkins University (Baltimore, MD)
- …research study to ensure validity of findings. Work with Principal Investigator or senior research staff to develop operational plans to meet research goals. Develop ... Preferred Qualifications Related undergraduate or work experience in research. Technical Skills & Expected Level of Proficiency Clinical Research Coordination… more
- Washington Metropolitan Area Transit Authority (Washington, DC)
- …10 Year Strategic Plan for Joint Development. The position will support the senior leadership of the Office technical , policy, communication and other matters ... 12/04/2025 - 12/19/2025 Union NRP Regular/Temporary: Regular **Job Description** ** Senior Program Coordinator Marketing Statement:** WMATA?s Office of Real Estate… more
- Johns Hopkins University (Baltimore, MD)
- …system or both. Works with departmental administrative and/or academic leadership or senior IT leadership to develop and implement plans for service delivery in ... frontline IT professionals, will act as a resource for staff including technical guidance, and may have some hands-on responsibilities. Recognized as an expert… more
- Johns Hopkins University (Baltimore, MD)
- …to the Associate Director of Building Operations. This position provides technical expertise to Facilities Maintenance and defines specific programs necessary to ... and programs are accomplished in accordance with statutory requirements and regulatory guidelines. Oversee parts, materials, and equipment inventories to ensure… more
- Oracle (Annapolis, MD)
- …AI-enabled population health platform. To support these efforts, we are hiring ** Regulatory Technical Documentation Engineers** with **deep engineering ... documentation + Experience preparing documentation for audits, technical files, or regulatory submissions. **Preferred** + Experience in healthcare,… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …post-approval supplements). Determine regulatory CMC content and scientific/ technical requirements to ensure documentation meets regulatory ... Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process...Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop… more
- Oracle (Annapolis, MD)
- …leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both ... and compliance activities** as HDI expands globally. Ensure operational processes and documentation align with regulatory standards and help drive readiness for… more
- Noblis (Washington, DC)
- …+ Minimum of **2 years of experience** producing or editing **FAA aviation regulatory documentation ** or related technical publications in aviation or ... Responsibilities **Overview** We are seeking an experienced ** Senior Technical Writer/Editor** with a deep...offices. + Familiarity with **FAA Orders, Advisory Circulars, and regulatory documentation standards** . + Experience developing… more
