- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory … more
- Merck & Co. (Upper Gwynedd, PA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory … more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep ... years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years… more
- Eisai, Inc (Nutley, NJ)
- …ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... of end-to-end clinical trials with the utmost compliance and quality consistent with Good ...and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … more
- Merck & Co. (North Wales, PA)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C...multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics;… more
- Merck & Co. (Rahway, NJ)
- …operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ... Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations.Current… more
- Novo Nordisk Inc. (San Francisco, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement ... in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or more years proficiency in ICH GCP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing… more
- Aequor (Athens, GA)
- …and Global Supply facilities, having direct impact on site performance including EHS, regulatory compliance , quality , future innovation timelines, and animal ... used in clean utilities. Ensure all maintenance activities comply with regulatory standards and safety protocols, including cleanliness of assigned facilities and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Provide high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling ... other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Insmed Incorporated (San Diego, CA)
- …of calibration and maintenance systems to ensure operational readiness and regulatory compliance . Responsibilities include leading the procurement, installation, ... and opportunities for productivity improvements.Develop and execute C&Q plans in compliance with internal procedures and regulatory standards.Lead CMMS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous… more
