- 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
- 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
- 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
- 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
- Merck & Co. (Boston, MA)
- …current with emerging pharmaceutical information tools and databasesSupporting document delivery requests and end-user requestsObtaining journal articles and ... clearly and concisely to diverse audiences, including researchers, clinicians, regulatory affairs professionals, and other stakeholdersCustomer Focus - Driven to… more
- Merck & Co. (Rahway, NJ)
- …areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management , regulatory . Good Manufacturing Practice (GMP) or related ... the disposition of API materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory… 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
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… 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. (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
- Aequor (East Syracuse, NY)
- …experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired. Experience ... and downstream manufacturing process development, characterization, and process improvements. Document and evaluate experimental results and perform data verification… 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
- 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
- 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
- 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
- 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 (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
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