- Merck & Co. (Rahway, NJ)
- …market authorization, execute of post marketing commitments and meet compliance obligations.Qualifications and Skills:Required: Global Regulatory experience ... will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS)...implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory … more
- 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)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over $30 ... before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global ... Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Eisai, Inc (Nutley, NJ)
- …company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads ... components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Merck & Co. (Rahway, NJ)
- …integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... Job DescriptionOur Company is a trusted global leader in human and veterinary medicine, dedicated...Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies,… 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. (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 benefit of patients and global human health.This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that all content, community interactions, and account activities comply with legal, regulatory , and corporate standards.- Collaborate with legal, compliance , and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of… 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 ... to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of...working closely with other research functions across our Company's global organization. The position is a key collaborator with… 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. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health. Responsibilities :Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under… more
- Merck & Co. (San Francisco, CA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Merck & Co. (Omaha, NE)
- …Management, Distribution Management, Driving Continuous Improvement, Foreign Trade, Global Manufacturing, Healthcare Innovation, Immunotherapy, Inbound ... closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so...Letters of Credit and insure we are shipping in compliance with our credit departmentReport out the export shipping… more
- Merck & Co. (Rahway, NJ)
- …Procurement, Procurement Management, Production Planning, Project Procurement Management, Regulatory Compliance , Risk Management, Stakeholder Engagement, ... execute a comprehensive regional and local strategy in line with the global strategy, including supplier management, compliance , risk management, diversity… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... technical skills, and scientific acumen as part of a global , cross-functional team . - Job Responsibilities - Responsible...clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and… more
