- 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. (Durham, NC)
- …Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...compliance with QMS process requirements across NNI and global as applicable Proactively identifies risks/quality drift in external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… 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. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... one medical device development or design controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...compliance with Deviation process requirements across NNI and global as applicable Develops and executes regular surveillance, follow-up,… more
- Merck & Co. (Rahway, NJ)
- …as well as combination product assembly processes.Extensive knowledge of US and global medical device and healthcare regulations, including FDA combination ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead… 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. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
