- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based in Raritan, NJ.Role OverviewThe QC Data ... Reviewer is an exempt level position responsible for reviewing...operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QC Microbiology Data Reviewer is an exempt level position with responsibilities for...and commercial operations in a controlled cGMP cleanroom environment.Create, review and approve relevant QC documents, logbooks, SOP's and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical documents and ensure accuracy and scientific balance. As part of the medical review team, the manager is responsible for conducting comprehensive ... external slide decks, summary cards, and other resources for use by Regional Medical AffairsConduct comprehensive medical review and clearance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …content to be used by Regional Medical Science Liaisons Oversee comprehensive medical review and clearance of materials/programs as member of the GMA ... team. Providing subject matter expertise to ensure comprehensive, high quality, medical review and appropriate sign-off/approval of materials/programs Serve as… more
- Sterling Medical Corporation (Columbus, OH)
- …patient registry. . You shall maintain accurate and current notes in the electronic medical records of all patients contacted for review by the managing ... General Description: Clinical Psychologist is required to function in a patient-centered medical home (PCMH) location as a full-time equivalent provider as an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... areas centered around rare diseases and immune disorders. Summary Director, Global Medical Affairs Oncology Publications works with Cross Functional Team to develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …FTE allocation, budget allocation, and assessment of needs including training, data review tools, etc. Standing PRG reviewer for mid-to-late-stage asset ... documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer 's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Spectraforce Technologies Inc (Atlanta, GA)
- …Team Lead and other client personnel to perform quality assurance reviews on medical records. The HEDIS Quality Assurance Nurse Reviewer will validate abstracted ... Title: Quality Assurance Nurse Reviewer (Overread Team), (100% Remote) Duration: 5 Months...other duties toward HEDIS collection as assigned including HEDIS medical record review and outreach for collection… more
- Careers Integrated Resources Inc (Atlanta, GA)
- …. 2 years clinical practice experience . 1 year experience in clinical auditing or medical review preferred . Knowledge of clinical data auditing or HHS risk ... Job Title: Risk Adjustment Clinical Reviewer Location: 100% Remote Duration: 2 Months (Possible...adjustment is helpful . Perform review on clinical data and abstract documentation to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. ... may serve as deputy compound lead in Global IIS Review Committee meetings.Leads external medical education and...in Global IIS Review Committee meetings.Leads external medical education and other scientific exchange activities in alignment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with ... workflow handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation and labels… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strategy, comparability plans and data governance initiativesProvide critical input and review for validation master plans, PPQ and comparability protocols and ... reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …generation strategies and activities as part of the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies ... Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across USOMA functions to develop, ...Medical Affairs and across USOMA functions to develop, review , and align on key scientific communications and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …information; continuing education; Medical Affairs compliance, oversight to the field-based Medical Liaison group; and medical review of promotional ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Philadelphia, PA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and materials that are relevant for global by conducting scientific review and approvals. Medical Communications and Publications: Drive publication planning ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...disorders. Summary The purpose of the Lead of Global Medical Affairs Oncology is to take the leadership position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... around rare diseases and immune disorders. SummaryThe Director, Global Oncology Medical Affairs, Evidence Generation role is responsible for co-leading a… more
