- Legend Biotech USA, Inc. (Raritan, NJ)
- …reconciliation.Key Responsibilities Day to day management of resources, planning and assigning work to Document Control Specialists to meet goals and ... deadlines.Serve as a Document Control reviewer for new and revised...handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation… more
- Merck & Co. (North Wales, PA)
- …support Health Technology Assessment (HTA)/ reimbursement/ National Immunization Technical Advisory Groups (NITAG)evaluations.Development of overall Real World ... value and use of our company's products.Implements programs to document the burden and cost of diseases, unmet medical...of the team.Present research plans and results to internal review and governance committees; to external experts and agencies… more
- Aequor (Golden Valley, MN)
- …related to the analysis of samples for Medallion Labs Document results and review data Investigate any technical discrepancies on a timely basis Develop a ... preferred. Ability to manually calculate analytical test results Demonstrated ability to work and communicate with people from technical , production, and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …complaints including handling of refund of replacement requests Perform data entry and review of adverse events and associated technical complaints and provide ... quality assessment of all inbound safety information, including adverse events and technical complaints, for Novo Nordisk Inc.'s (NNI) US marketed products (drugs… more
- Merck & Co. (North Wales, PA)
- …regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... business processes and systems.Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development methodologies Excellent technical writing, document organization, technical document review and analytical thinking skills Excellent ... the most of their talent, and we reward hard work and dedication with opportunities for continuous learning and..."Senior Architect - Data Management & AI" is a technical leader with a deep understanding of business goals,… more
- Aequor (Thousand Oaks, CA)
- …and portfolio skills. This position is a key member of the GxP Management Review Governance Team within the Quality Systems and Services organization. The QA Sr ... Governance, will execute required activities to coordinate, prepare, execute and document the execution of GxP Quality Management Reviews. Position Responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity. The incumbent is responsible for authoring, ... review and manage the development of internal procedures to...reports. Provide the support for management and update of technical registration documents- Quality Metrics: Collecting and analyzing data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support new and existing functionality. Responsible for the development of the Technical Design Document to ensure all requirements have been met. Responsible ... business requirements. Additionally, it provides expertise in both functional and technical aspects to guide the design and integration of enhancements or… more
- Aequor (Bothell, WA)
- … review and/or approve applicable CSV documentation Assist Business Owners and Technical Owners during test execution, document test failures and ensure ... technical and problem-solving skills and the ability to work independently. Demonstrated success working in a high-performing, business results-driven… more
- Merck & Co. (Rahway, NJ)
- …assess various technology solutions applicable to requirements.Actively participate in the technical implementation and support of key applications to help ensure ... with our vendors to optimize solutions and enhance product capabilities for added value. Work within agile teams and contribute to common goals.Thrive in a dynamic,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. They ... technical and manufacturing operations for quality oversightAbility to work independently and successfully prioritize multiple tasks simultaneouslyPerform tasks… more
- Insmed Incorporated (San Diego, CA)
- …the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values ... we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning...QA oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records. Will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in trackers) Review the CRO partner Sample Management Plan, to document cross-functional agreements on the tracking, lifecycle and reconciliation plan for each ... associated study Informed Consent Forms (ICFs). The role is expected to work in close collaboration with several cross-functional internal and external stakeholders… more
- BioAgilytix (Durham, NC)
- …professional and technical knowledge by attending educational workshops; review professional publications; establish personal networksAssist in document ... culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career...and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Non-clinical Development. Essential Functions Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which ... submissions Shares knowledge and experience to optimize and simplify the way we work Reviews proposed study plans and related documents for their ability to deliver… more
- University of Maryland Medical System (Mount Vernon, MD)
- …the Inner Harbor and Camden Yards, you won't find a more vibrant place to work ! And UMMC Midtown Campus, one of two campuses of the University of Maryland Medical ... Lab Supervisor and performs all required ultrasound and clinical evaluations at a technical level requiring limited supervision. The VT maintains a high standard of… more
- Koniag Government Services (Germantown, MD)
- …Professional Services, LLC,** a Koniag Government Services company **,** is seeking a Document Reviewer Level 5 (DRL5) with Top- Secret clearance to support ... a Koniag Government Services company, is seeking an experienced Document Reviewer Level 5 to join a...+ Strong analytical skills and attention to detail in document review and analysis. + Excellent communication… more
- Koniag Government Services (Germantown, MD)
- …Professional Services, LLC,** a Koniag Government Services company, is seeking a Lead Document Reviewer Level 5 (DRL5) with Top- Secret clearance to support ... and more. Koniag Government Services is seeking experienced Lead Document Reviewers Level 5 (DRL5) to join a dynamic...(DD) + Excellent communication skills and the ability to work effectively with technical experts + Familiarity… more
- Cambrex High Point (Durham, NC)
- …around the world. Start a career where You Matter by applying today! Job Overview The Technical Reviewer will work independently to provide a technical ... for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a...paced environment. Responsibilities + Responsible for performing an independent technical review of all analytical (small and… more
