- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- USAA (Colorado Springs, CO)
- …multiple business applications Ability to apply knowledge and understanding of insurance regulatory and compliance requirements Acquire Property & Casualty ... Opportunity It is all about learning and growing. Our Insurance Customer Service role may be a new career...1855 Telstar Dr, Colorado Spring, CO 80920, for future insurance sales and customer service opportunities in 2025 .… more
- USAA (Phoenix, AZ)
- …Prior experience leading aP&L and operating within best interest rule, state insurance regulatory licensing, approval, and regulatory requirements. ... Executive level experience in the areas of Property and casualty, life insurance or financial services industry CFP certification The above description reflects the… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Durham, NC)
- …The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to EHS as ... of required reports to site, divisional and/or corporate management and regulatory agencies.Manage budgetary & capital needs to support EHS initiatives, projects… more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- …with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other...of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Merck & Co. (Rahway, NJ)
- …of CAPA implementation and effectiveness to ensure no recurrence of findingsGather regulatory intelligence and partner with our Company and CMO management to prepare ... and Regional Quality/Management councilsProvide guidance and consultation services for regulatory reporting (eg, BPDR, DPR)Author and/or review global standards and… 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. (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
- Merck & Co. (South San Francisco, CA)
- …enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role in developing, ... GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of an interdisciplinary team… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k),… 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. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
