- Merck & Co. (Upper Gwynedd, PA)
- …development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership ... per established business processes and systems.-Identify, communicate and escalate potential regulatory issues to GRACS CMC management , as neededDemonstrate an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or more years ... around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit activities per audit program of GxP… more
- Merck & Co. (Rahway, NJ)
- …Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management , Regulatory Affairs Compliance {+ 4 more}-Preferred ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Twist BioScience (South San Francisco, CA)
- … Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety ... Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key markets (Required)2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: ... other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory… more
- Aequor (Athens, GA)
- …management systems and migration of records from legacy systems. Electronic Document Management (controlled documents, regulatory submission documents): ... site users in workflow configuration. Provide routine user support. Electronic Document Management (controlled documents, regulatory submission documents):… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of PV Regulatory … more
- Aequor (Thousand Oaks, CA)
- …with an appropriate risk-based approach, eg. reduced SDV etc Develop and document standard operating procedures (SOPs) for data management activities Process ... processes Regulatory Compliance and Quality Assurance: Ensure all data management activities comply with regulatory standards (eg, FDA, EMA, ICH-GCP).… more
- Genmab (NJ)
- …MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (South San Francisco, CA)
- …and development. PDMB aims to leverage Generative AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory ... GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of an interdisciplinary team… more
- Merck & Co. (North Wales, PA)
- …and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market ... care systems that can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported… more
- Merck & Co. (Rahway, NJ)
- …collaborative projects and develop subject matter expertise- - Knowledge of order management , supply chain operations and document control - #MSJR ... Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address...At least 5 year s of experience in project management - - At least 5 years of experience in… more
- Genmab (NJ)
- …and ICH guidelines.Proficiency with writing tools such as MS Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical ... the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a...of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help… more
- Merck & Co. (Durham, NC)
- …Required: -Project Management experienceStrong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP ... Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, support may extend… more
- AUROBINDO (Dayton, OH)
- …portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality ... control and regulatory affairs. In addition to several formulations under manufacture,...Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.5. Prepare and/or… more
- Merck & Co. (Durham, NC)
- …of experience in field calibration, metrology or equipment reliability.Project Management experienceFamiliarity of regulatory requirements in accordance with ... Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects when necessary. At times, support… more
- Merck & Co. (Rahway, NJ)
- …biostatisticians and/or epidemiologists within BARDS, as well as stakeholders in data management , medical writing, and clinical operations to gather and document ... Generate tables, listings, and graphics required for clinical trial decision-making, regulatory requests, clinical study reports, and new drug application filing.… more
- Eisai, Inc (Nutley, NJ)
- …for the clinical team for designated projects, communications, and associated documentation Document Creation and Management : Assist with creating, updating and ... regulatory packet for investigational product releaseProvide user access management support ; tracking certifications and maintain statuses of study team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of direct reports, ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
