- Genmab (Plainsboro, NJ)
- …and TMFs. Contribute to the development of other documentation such as: Investigator 's Brochures, Subject Informed Consent, and Development Safety Update ... be our best, and authentic is essential to fulfilling our purpose.RolePerform safety review of Adverse Event reports for Genmab products. Perform ongoing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …visibility and independent interaction with the business globally Establishment of the product safety profile Develop and update the minimum mandatory ... Surveillance will resume chairmanship going forward Establish, operate and chairs the safety committee throughout lifecycle of the actual product Responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety ...other clinical study documentsAuthors or oversees the development of safety sections of Investigator 's Brochure, aggregate reports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The… more
- Eisai, Inc (Nutley, NJ)
- …list for Eisai systems eg. eTMF, EDC, IRT Assist with tracking SAE safety reports, collating information and providing updates to the CRO Initiates, tracks and ... vendor teleconferences as applicable Review regulatory packet for investigational product release Provide user access management support ; tracking certifications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Insmed Incorporated (San Diego, CA)
- …company at regulatory meetings including presentation at Advisory Committee Meetings.Preparing safety charters, DMC charters, or other specific management plans and ... team.Supporting or preparing data interpretation and clinical trial reports.Preparing Investigator Alert letters and SAE reports in collaboration with Clinical… more
- Genmab (Plainsboro, NJ)
- …will be a key member of the USMA leadership team, contributing to product launches & development efforts, responsible for shaping team culture & employee ... of US needsProvides scientific input and strategic direction to the investigator -sponsored trial program for solid tumor assets/disease and participates in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators ... to team members and track them to completionFollow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.Perform… more
- GE Aerospace (Evendale, OH)
- …Cost-in that order for a reason. Safety comes first at GE Aerospace. The Product Safety Investigator for Flight Safety , Commercial Engines will act ... As part of the GE Aerospace Safety Management System (SMS), the Product Safety Investigator is responsible for implementing and enhancement of safety … more
- Intuit (Atlanta, GA)
- Overview We are seeking a highly skilled Trust and Safety Content Safety Investigator to join our team in Atlanta. In this hybrid role, you will play a ... critical part in ensuring the safety and integrity of content across Intuit's platforms. You...potential risks + Collaborate with cross-functional teams, including legal, product , analytics, and policy to address content-related issues and… more
- State of Massachusetts (Worcester, MA)
- …with the regulations (examples of specific policies may include: security policies; product safety policies, sanitation, and wasted i sposal policies). Conducts ... *_ PURPOSE OF THE JOB_* The Cannabis Control Commission Investigator conducts inspections and investigations of licensed marijuana establishments in the Commonwealth… more
- State of Colorado (Lakewood, CO)
- …Regulations. + Supports and conducts prioritized investigations into youth access and product safety -related cases, leveraging Division tools such as the ... COMPLIANCE INVESTIGATOR II - Natural Medicine Division Print (https://www.governmentjobs.com/careers/colorado/jobs/newprint/4705374) Apply COMPLIANCE … more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator II in Albuquerque, NM Summary: Curia provides global contract research and manufacturing services to the pharmaceutical and ... biotechnology industries. The Quality Deviation Investigator (QDI) II is responsible for leading investigations to ensure the written report contains technical merit… more
- Dollar Tree (Kansas City, MO)
- …and compliance to include Cash Management, Loss Prevention, Physical Security, Safety , Robbery Prevention, Product Freshness and Display Compliance. Assist ... General Summary: The Market Investigator is responsible for confirming that the market's...in these categories: Office/Cash Sales, Loss Prevention, Physical Security, Safety and Personnel Training and Development. This position will… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …**Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) ... required ( safety glasses, gowning, gloves, lab coat, ear plugs etc.)...the quality impact on both the patient and the product is assessed against applicable regulatory guidelines. + Identify… more
- Catalent Pharma Solutions (Harmans, MD)
- …a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. **The role:** + Ensure that ... + Maintain departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities. + Support client and… more
- BeiGene (Emeryville, CA)
- …monitoring plans + Participates in investigator meetings, as needed, accountable for product safety profile and reviews, approvals and updates of safety ... The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often… more
