- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality ... (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior … more
- Merck & Co. (Upper Gwynedd, PA)
- …Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Merck & Co. (Rahway, NJ)
- …in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Tris Pharma (Monmouth Junction, NJ)
- …inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Provide high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling ... other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
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