- Merck & Co. (Rahway, NJ)
- …, Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, ... and dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC) , Pre-approval Pharm will… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- …Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs ... development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and design… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible...cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
- Merck & Co. (Rahway, NJ)
- …risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. ... Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality, Compliance , Supply Chain and Commercial. ... Product Leaders have direct impact on cost, quality, customer service, and compliance which ultimately affects access, continuity of supply, and commercial outcomes.… more
- Merck & Co. (Rahway, NJ)
- …platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Eisai, Inc (Nutley, NJ)
- …significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA ... #LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote -Based is from :236,900-310,900Under… more
- Merck & Co. (Rahway, NJ)
- …and Health, Pharmaceutical Guidelines, Process Safety, Project Human Resource Management, Regulatory Compliance , Safety Audits, Standards Compliance , ... protection and initiate appropriate action.Lead site and/or local area audits for compliance with applicable regulatory requirements (ie OSHA, EPA, DEP, etc.).… more
- Sandoz Group AG (Princeton, NJ)
- …personally. Join us as a Founder of our 'new' Sandoz! As the Associate Director , Market Product Quality you will be responsible for the execution of processes ... for impact to Sandoz rules and policies. *Supports the organization's compliance with DEA regulations, including required reporting, audit support and… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance , Regulatory Requirements, Safety Standards, ... from the Operations Director .Works within budgetary/financial objectives set by Director - Compliance - Responsible for creating and sustaining a culture that… more
- Merck & Co. (Rahway, NJ)
- …platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and ... Job DescriptionReporting into the Director Packaging Platform Technical Leadership the Associate ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- …Procurement Strategies, Production Planning, Project Management, Project Procurement Management, Regulatory Compliance , Risk Management, Strategic Procurement {+ ... Job Description Role Summary The Associate Director of Procurement for Capital Projects will be...project procurement planning, supplier management, contract negotiations, and ensuring compliance with company policies and processes. - Reporting to… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... - Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) and...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Prime Therapeutics (Trenton, NJ)
- …our passion and drives every decision we make. **Job Posting Title** Director , Compliance ( Regulatory ) - Remote **Job Description** The Director of ... to internal and external leaders regarding escalated legal and compliance issues, regulatory and client audits; serves as primary contact for assigned… more
