- BioAgilytix (Durham, NC)
- …ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical ... OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work closely with the scientific staff to ensure data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an exempt level position responsible for reviewing...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)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview ... The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...commercial operations in a controlled cGMP cleanroom environment. Create, review and approve relevant QC documents, logbooks, SOP's and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of medical review , providing expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and ... Associate Director (AD) is responsible for overseeing all activities related to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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 (Columbia, SC)
- Job Title: Medical Reviewer I Location: Columbia, SC 29203 ( 3-4 weeks onsite training then Remote) Shift: M-F, 8AM-4:30PM Payrate: $24/hr Duration: 7 months ... decisions using indicated protocol sets or clinical guidelines. Provides support and review of medical claims and utilization practices. Responsibilities: 80%… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …allocation, budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage asset protocolsCore ... 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
- BioAgilytix (Boston, MA)
- …II/III will perform responsibilities of a traditional lab analyst, peer reviewer , and new system implementation specialist. Tasks will encompass running assays, ... analysis projectsTroubleshoot assaysCompile/process data (make power export)Prepare summary tablesPeer review raw dataOrder reagentsParticipate in assay development and validationResponsible… more
- Eisai, Inc (Nutley, NJ)
- …this role is responsible for developing and executing the global medical affairs plan, including peer-reviewed review /perspective publications, medical ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...in the AD space with original contribution to drafting review /perspective articles for peer-reviewed journals; Liaise with external co-authors,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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)
- Job DescriptionDescription: The Associate Principal Scientist, Oncology Publications Medical Writing, works with scientists in our company's Research Labs and ... and Real-World Evidence, Global Discovery, Preclinical and Translational Medicine, Global Medical and Scientific Affairs, and Global Regulatory Affairs and Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company and clinical site investigators and KOLs Interface together with VP Medical /Scientific Development with Safety Review Committees and Data Safety ... Monitoring Committees Participate in safety review meetings and providing medical monitoring of ongoing clinical trials Physical Requirements 10-20% overnight… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project teams to manage preparation of the ... clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The… more
- Eisai, Inc (Nutley, NJ)
- …internal business processes including leading and/or active participation in relevant medical review committees.Partner with key internal stakeholders to support ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...Phase IV clinical development programs for assigned products.Design and review IIS strategies and review proposals in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Gains strategic and planning alignment across regions and functions, and supports review of local country/regional Medical Affairs activities when applicable. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... and make a difference. If this is your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical … more
