- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/Senior Director, the Principal ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Merck & Co. (Rahway, NJ)
- …industry best practices and leads knowledge management regarding important regulatory developments.Leads/co-leads and acts as advisor/consultant for any of our ... GCP inspections to ensure that all phases of Health Authority/ Regulatory inspections (ie, notification, pre-inspection preparation activities, inspection liaison… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Program Leadership and Technical Project ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… 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 ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and other Company Research… more
- Merck & Co. (Rahway, NJ)
- …biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory ... team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures and… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key our Company functions.Represent Device… more
- Merck & Co. (Rahway, NJ)
- …compatibility characterization for processing and administration, and supporting regulatory filings.Build deep fundamental knowledge around the drug product ... to ensure completion of key milestones and laboratory / regulatory documentation.Active strategic and technical leadership on program development teams, interfacing… more
- Merck & Co. (Rahway, NJ)
- …validation, analysis and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. ... Principal Scientist will work closely with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA… 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 ... 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)
- …oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... lifecycle, as well as responding to agency questions.-Scientific Excellence and Regulatory Influence:Promoting our company's scientific excellence and regulatory … more
- Merck & Co. (Rahway, NJ)
- …pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May ... 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)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule ... development to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program development teams,… more
- BioAgilytix (Durham, NC)
- …responsibilities; responsible for overseeing on-time availability of samples and regulatory (GxP, CDX-CAP/CLIA) compliant processing of samples; and scheduling the ... tours of sample management areaGenerates and maintains records in a regulatory compliant mannerContributes to oversight of Sample Management laboratory, including… 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)
- …or business associations responsible for healthcare, commercial trade, regulatory , or intellectual property. Government experience preferred.-Pharmaceutical sector, ... processes in large, complex organizations.Ability to master complex policy, regulatory and legislative issues, think creatively and develop innovative strategies… more
- Merck & Co. (Rahway, NJ)
- …as companion diagnostics. The position is also responsible for supporting regulatory filing related to oncology biomarkers. -This position requires solid statistical ... development including cut point selection and bridging analysis for regulatory approval.Interacts with Discovery and Translational, Clinical, Regulatory ,… more
- Merck & Co. (Rahway, NJ)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for ... software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic… more
- Merck & Co. (Rahway, NJ)
- …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)
- …America and Europe.Preferred candidates will have a strong working knowledge of regulatory and compliance laws, including the US Foreign Corruption Practices Act ... Spanish, is strongly preferred. Qualifications: Education Requirement: License to practice law (active in good standing) in at least one US jurisdictionAdvanced… more
