- Exela Pharma Sciences, LLC (Lenoir, NC)
- …documentation. This position will additionally serve as a final Quality Reviewer /Approver for internal documentation. The Documentation Control Supervisor is also ... initiatives. Job ResponsibilitiesManages the Documentation Control Unit to ensure the following: Document Change Controls (DCCs) are processed in a timely manner,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …work to Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure ... 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… more
- Merck & Co. (North Wales, PA)
- …that can enhance value and use of our company's products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported ... and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Landscape Develop and maintain overview of Development SOP and associated document landscape including planned new documents, changes, and retirements. Create ... with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate… 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
- 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
- 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)
- …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)
- …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
- 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)
- …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
- Aequor (Golden Valley, MN)
- …support and flexibility related to the analysis of samples for Medallion Labs Document results and review data Investigate any technical discrepancies on a ... and serial dilutions Knowledge of laboratory quality systems, statistics, and document control. ISO 17025 experience preferred. Ability to manually calculate… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including handling of refund of replacement requests Perform data entry and review of adverse events and associated technical complaints and provide ongoing feedback ... case quality Handle incoming and outgoing follow-up correspondence Collect and document information received during outbound follow-up calls Perform triage, case… more
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