- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- USAA (Colorado Springs, CO)
- …through multiple business applications Ability to apply knowledge and understanding of insurance regulatory and compliance requirements Acquire Property & ... Opportunity It is all about learning and growing. Our Insurance Customer Service role may be a new career...measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: High School… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Merck & Co. (Rahway, NJ)
- …Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance , Regulatory Inspections, Vaccine ... procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate in industry organizations… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance , Regulatory Reporting, ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- BioAgilytix (Durham, NC)
- …and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Merck & Co. (North Wales, PA)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… 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 ... 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. (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
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Durham, NC)
- …process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or ... to meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and… more
