- 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)
- …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. (South San Francisco, CA)
- …you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and ... AI/ML to support efforts in transforming the way PDMB leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused… 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
- Aequor (East Syracuse, NY)
- …used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and ... in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.Experience authoring,… 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 ... you ready to make a meaningful impact in oncology drug development and be part of a dynamic, collaborative...the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a… 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 ... can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical...need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process… 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..., visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for… 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 ... the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate...with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs… more
- Merck & Co. (Rahway, NJ)
- …Generate tables, listings, and graphics required for clinical trial decision-making, regulatory requests, clinical study reports, and new drug application ... biostatisticians and/or epidemiologists within BARDS, as well as stakeholders in data management , medical writing, and clinical operations to gather and document … 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
- Lilly (Lebanon, IN)
- …**Role Description** Responsible for implementing and maintaining the Procedures and Document Management process. Includes Good Manufacturing Practice (GMP) ... regulations and document control processes. + Experience with electronic document management systems. + Excellent organizational and communication skills. +… more
- Catalent Pharma Solutions (Harmans, MD)
- …+ Responsible for implementation, management , and enhancements of an electronic Document Management System (eDMS). **The candidate:** + Bachelor in a Life ... lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval,… more
- Integra LifeSciences (Princeton, NJ)
- …and oversee quality and compliance improvement and remediation strategies for document and record control, change management , and training administration ... and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the...and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design,… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …and management , metadata standards and data discoverability; Maintain the Regulatory Data Catalog: Document Data classification and quality rules; Identify ... including regulatory submissions, labeling, and product tracking; Oversee Regulatory Document data classification rules, compliance/retention rules, and… more
- Wells Fargo (San Francisco, CA)
- …in complex negotiations. + **Deliver Strategic Insights** : Advise senior management on market trends, regulatory developments, and negotiation strategies ... and oversight of a wide range of documentation, ensuring alignment with regulatory requirements, internal risk frameworks, and market best practices. You will serve… more
- Chiesi (Cary, NC)
- …FDA OPDP + Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus + Demonstrated expertise in regulatory ... guidance documents that impact domestic and international activities related to Regulatory activities. + Interact with senior management , external departments… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Merck (Boston, MA)
- …Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management , Regulatory Affairs Compliance {+ 4 more} **Preferred ... **Job Description** Position Description: The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global … more
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