- Merck & Co. (Rahway, NJ)
- …- Precision - Accomplishment - Motivational Ambition - Respect - InclusionDevelops worldwide product regulatory strategy to optimize product labeling and ... Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison...submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Global Regulatory Submissions, Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance , Regulatory ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… 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 ... Support, Occupational Health and Safety Management, Pharmaceutical Manufacturing, Regulations, Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting End… more
- Merck & Co. (Rahway, NJ)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie… more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... in their HTA submissions. The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that the… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... physicians and scientists across various regions, offering guidance and support to each product safety team in critical areas such as individual case medical review,… more
- Eisai, Inc (New York, NY)
- …products, compliance statements, audit certifications, and safety issues for regulatory submission. May use six-sigma methodology. May provide training on GCP ... accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological...and compilation and interpretation of safety data to support product strategies. May plan and prepare report drafts for… more
- Formation Bio (New York, NY)
- …operating procedures (SOPs) in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, review ... for the development, optimization, and validation of drug substance and drug product analytical methods to support the development and manufacturing of large… 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 ... drugs in our company's pipeline, with a deep understanding of product development from early stage through commercialization.Actively partnering with other… more
- Merck & Co. (Rahway, NJ)
- …Trade Finance, International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Problem Solving, Process Improvements, ... Research & Development Division scientists, our Manufacturing Division and Animal Health product experts, global regulatory , controlled substances and others to… more
- Merck & Co. (Rahway, NJ)
- …Trade Finance, International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Process Improvements, Project Management, ... Reporting to the Customs & International Trade (CIT) Valuation Associate Director , the Senior Specialist position's core responsibilities are to oversee our… more
- Merck & Co. (Rahway, NJ)
- …, Innovation, Management Process, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Management Leadership, Results-Oriented, ... Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing...leading the DCT at Line of Sight to Commercial Product Definition.- This pivotal role encompasses both technical and… 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 ... stability assays for testing of clinical trial material and in support of product and process development.A strong team player with excellent oral and written… more
- Ross Stores, Inc. (New York, NY)
- …learning opportunities and development for our teams\. **GENERAL PURPOSE:** The Director , Product Compliance & Regulatory Attorney will work as a member ... stakeholders on a broad range of topics and projects in the areas of product compliance , regulatory compliance , product safety, environmental, and… more
- Merck (Rahway, NJ)
- …| Accomplishment | Motivational Ambition | Respect | Inclusion + Develops worldwide product regulatory strategy to optimize product labeling and obtain ... **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is...submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and… more
- Bayer (Whippany, NJ)
- …Code:** 842231 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Medical Device, Regulatory Affairs, Biomedical Engineering, Compliance , Product ... to make a real difference, there's only one choice.** ** Director , Global Regulatory Strategist, CGT Combination Products**...& Gene Therapy (CGT) Combination Products requires a Global Regulatory Expert who can lead Combination Product … more
