- 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 ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Landscape Develop and maintain overview of Development SOP and associated document landscape including planned new documents, changes, and retirements. Create… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity. The incumbent is responsible for authoring, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... focus on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... to meet obligations related to the development, co-promotion, out-license, etc. of pharmaceutical products. Extensive knowledge and expertise in the use of program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …option 12 weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and ... to realize your potential? The Position Contribute to the delivery of Active Pharmaceutical Ingredients (API) as agreed to in the site production & capacity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... and enterprise scheduler operational issues. Track problems and incidents and document status from team members and communicate status and system performance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds ... and Non-clinical Development. Essential Functions Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide… 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 ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and ... with the compounding of various commercial and research drug products and formulations. Document batch records with the utmost attention to detail using cGMP… 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)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... and existing functionality. Responsible for the development of the Technical Design Document to ensure all requirements have been met. Responsible for reviewing unit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... in design and geographic scope). Prepares clinical section of regulatory document . Collaborates as team member with AROs/CROs. Drafts development plans, protocol… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …phases of the project and system development methodologies Excellent technical writing, document organization, technical document review and analytical ... negotiation, written and oral communication skills Preferred Skills Knowledge of Pharmaceutical Data like IQVIA, Komodo, Veeva, Customer or Product Master Systems… more
