- Primastep LLC (Arlington, VA)
- Company Description Job Description We are seeking a qualified HRPP Regulatory Compliance Specialist to support the Office of Naval Research (ONR) in Arlington, ... The ideal candidate will have a strong background in HRPP oversight, regulatory compliance , and program evaluation, along with excellent analytical and… more
- Merck & Co. (San Diego, CA)
- …Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical ... Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , Regulatory Reviews, Regulatory … more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- Merck & Co. (Durham, NC)
- …Reviews, Operations Support, Process Optimization, Production Scheduling, Production Support, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting End ... Conforms to established safety procedures in accordance with OSHA and other regulatory agencies- Identifies and addresses compliance , environmental, safety, and… more
- Merck & Co. (Rahway, NJ)
- …proactively and result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & ... ICH GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, Strategic Planning,… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …product profile (TPP) development, due diligence projects, and clinical- regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical ... success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance : Ensure adherence to FDA guidelines for 505(b)(2)… more
- Merck & Co. (Rahway, NJ)
- …to manufacturing, ensuring robust introduction, qualification, and performance monitoring. Regulatory Compliance :Collaborate closely with R&D and Manufacturing ... systems, including knowledge of damage mechanisms, common defects, and performance testing. Regulatory Compliance :Strong knowledge of relevant regulatory … more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in ... are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site procedures.Support … 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Insmed Incorporated (San Diego, CA)
- …technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all phases of clinical developmentTeam ... comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP)… more
- Merck & Co. (Durham, NC)
- …Engineering Standards, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise.This role requires a… more
- Merck & Co. (Durham, NC)
- …Interpersonal Relationships, Lean Manufacturing, Management Process, Manufacturing Scale-Up, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise. This role requires… more
- Merck & Co. (Rahway, NJ)
- …Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Leadership, Scientific ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance - Ensures that Data Management Plans are consistent and… more
- Merck & Co. (Rahway, NJ)
- …construction and campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with internal ... and building design standards, open space and site planning guidelines, and regulatory compliance such as ADA, environmental, and building codes.Ensure quality… more
- Merck & Co. (Upper Gwynedd, PA)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior… more
- Merck & Co. (Rahway, NJ)
- …Research, Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Consulting {+ 1 ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be… more
- Merck & Co. (Boston, MA)
- …Research, Mentorship, Parasitology, Patient Care, Professional Networking, Protocol Development, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting ... and clinical research methodology and biostatistics principles.Prior experience in drafting regulatory documents and interactions with global regulatory agencies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety...management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
