- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Safety Management. Daily internal interactions with personnel from Patient Safety , Medical Information, Field Sales, Customer Complaints Center, Suppliers ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Safety Management. Daily internal interactions with personnel from Patient Safety , Medical Information, Field Sales, Customer Complaints Center, Suppliers ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk...implementation of corrective actions for issues identified during case review Coordinate configuration requests for the safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates ... relevant medical topics, and supports PV Operations' medical review function. This position supports a...medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing… more
- Taiho Oncology (TX)
- …Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical ... Medical Science Liaison Texas, USA Virtual Req #330...Investigator-Initiated Trials (IITs) and HCP initiated projects. Facilitate the review and follow-up of submitted IITs. Assist with Taiho… more
- Uline (Columbus, OH)
- …and monitor safety goals.Take part in new product / process review , including process hazard analysis.Participate on Uline's Safety Committee. Review ... Columbus, Ohio Safety Coordinator Join Uline as we expand our...packages weighing up to 50 - 70 lbs. BenefitsComplete medical , dental, vision and life insurance coverage, Flexible Spending… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product safety lead… more
- Eisai, Inc (NJ)
- …grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...including (but not limited to) CRC, scientific communications, publication planning/ review , advisory boards, health outcomes plans, MSL activities, speaker… more
- Eisai, Inc (Nutley, NJ)
- …grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...including (but not limited to) CRC, scientific communications, publication planning/ review , advisory boards, health outcomes plans, MSL activities, speaker… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, ... medical history, and medications when needed- Addresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, ... allocation, budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage asset protocolsCore… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …oversight and management of all contract and vendor related activities in Patient Safety including, but not limited to, contract review and vendor management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...requirements. Relationships This position reports to the Director, Case Review & Compliance Reporting within Patient Safety .… more
- Merck & Co. (North Wales, PA)
- …worldwide to engage on statistical issues associated with the ongoing aggregate review of safety .-Prepare oral or written reports to effectively communicate ... analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent… more
- OU Health (Oklahoma City, OK)
- …chart reviews, provider and staff interviews and consultation with Patient Safety Medical Directors.Facilitates Root Cause Analysis meetings and communicates ... Position Title:RN Supervisor - Registered Nurse - Clinical Safety ProgramDepartment:Patient Safety DepartmentJob Description:General Description: Position is… more
- Aequor (KS)
- …plan) assigned and overseen by the supervising medical monitor in the study. Data review could be safety or efficacy or any other assigned by and supervised ... by medical monitor. Assists medical monitor in other...tasks as required, such as creation of PowerPoints for safety surveillance meetings, literature reviews, data cleaning, review… more
- Eisai, Inc (Nutley, NJ)
- …and their staff regarding AE's from clinical trials. 30%Assist in projects requiring review and assessment of medical information obtained or related to adverse ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...event reports received for assigned product, including the timely review and distribution to co-marketing partners and Eisai affiliate… more
- Tris Pharma (Monmouth Junction, NJ)
- …and/or leads, key Drug Safety activities including, but not limited to: safety data review , signal detection, risk communication including safety ... immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety . The Director, Drug Safety is responsible for planning, directing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors ... of external data across programs. Monitor vendor performance by collection and review of metrics and key performance indicators such as successful achievement of… more
- Novo Nordisk Inc. (Boulder, CO)
- …NN TRU Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters ... valued vendors. Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on… more
