- Novo Nordisk Inc. (Plainsboro, NJ)
- …phases of the project and system development methodologies Excellent technical writing, document organization, technical document review and analytical ... thinking skills Excellent presentation skills with knowledge of various presentation frameworks for persuasion Excellent interpersonal, negotiation, written and oral communication skills Preferred Skills Knowledge of Pharmaceutical Data like IQVIA, Komodo,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will also provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. ... They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues.Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Document Control Lead role is an exempt level position...handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …initiatives. Job ResponsibilitiesManages the Documentation Control Unit to ensure the following: Document Change Controls (DCCs) are processed in a timely manner, ... (SOPs), Facility Maps, etc.].Oversees the Equipment/Facility/Process (EFP) Change Control Program. Review all documentation associated with EFP Change Controls and… more
- Aequor (Fort Worth, TX)
- …trouble shooting, support investigation per standards/SOPs as needed. Write or review validation protocols and technical reports. Review internal documents ... / external documents, make recommendation as needed. Collect, calculate, interpret, document and report test results per ALCOA principles. Write and take ownership… 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)
- …on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... regulatory submissions.Support FDA meeting preparation including preparation of briefing document , meeting request, response to FDA preliminary comments and… 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...requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other ... Ensure key messages are clear and consistent within and across documents.Critically review documents produced by other writers for scientific content and alignment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other ... Ensure key messages are clear and consistent within and across documentsCritically review documents produced by other writers for scientific content and alignment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and enterprise scheduler operational issues. Track problems and incidents and document status from team members and communicate status and system performance ... for the EDW, integration, enterprise scheduling, and database environments. Continuously review performance of internal and external monitoring processes and tools… more
- Insmed Incorporated (San Diego, CA)
- …responsibility for the QA oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records. Will also provide QA support ... investigations, Change Control and CAPA/Effectiveness Checks. Provide expert QA review , collaboration, and direction for laboratory investigations.Apply Quality Risk… 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 ... up on the requests/escalation as needed. Process Documentation and ImprovementSupport review of study documents that pertain to biosample collection, handling, and… more
- SJ Hollander Architect (St. Charles, MO)
- … review shop drawings, attend client meetings and field document existing conditions. Required Qualifications: 1-5 years of prior architectural office ... is for you. The primary responsibility of this position is construction document preparation. You will also assist with design development, coordinate with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with the compounding of various commercial and research drug products and formulations. Document batch records with the utmost attention to detail using cGMP ... needed.Perform verifications and calibrations, such as balance, pH and DO. Review and understand applicable department standard operating procedures and… more
- Aequor (Austin, TX)
- …PLEASE SUB AT MARKET RATE! CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME: (1) Please confirm that you have hands-on experience with an ... use Ariba to process the final Master Agreement for review and obtain the electronic signatures. If experience is...Project Sourcing Plan with Project Manager as a \"living document \" throughout project life cycle Lead selection of Project… more
