- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP , GPV, GPEP, Data Protection, and other ... audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the… more
- Eisai, Inc (Nutley, NJ)
- …risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/ GCP guidelines and local regulations, ensuring ... Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align outsourcing strategies with… more
- Repligen (Waltham, MA)
- …& ITGC ComplianceWe are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls ... Four experience a plus).Familiarity with cloud security controls (AWS, Azure, GCP ).Strong analytical skills with experience identifying control gaps and developing… more
- Merck & Co. (Rahway, NJ)
- … Compliance , Ethical Standards, GLP Regulations, Good Clinical Practice ( GCP ), Machine Learning (ML), Marketing, Medical Laboratories, Medical Writing, Multiple ... the candidate be responsible for the conduct of Good Clinical Practice ( GCP ) studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate… more
- Insmed Incorporated (NJ)
- …including timelines, budget, data delivery and reporting, vendor management, GCP , etc.Develops operational strategies for implementation of clinical studies ... the development and review of regional/global policies and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.Work with… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and ... Proficiency in enterprise systems and a deep understanding of ICH/ GCP guidelines and pharmaceutical operations are essential for success.Essential Functions… more
- Merck & Co. (Salt Lake City, UT)
- …field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesEducationM.D., Ph.D. Pharm.D. or ... Collaborating, Communication, Diversity and Inclusion (D&I), Good Clinical Practice ( GCP ), Leadership, Medical Affairs, Motivation Management, Outcomes Research, Pharmaceutical… more
- Formation Bio (New York, NY)
- …you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good ... Laboratory Practices (GLP), Good Clinical Practices ( GCP ), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities… more
- Formation Bio (New York, NY)
- …clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving ... forecasts, and resource allocation. Ensure all clinical trials comply with ICH- GCP , FDA regulations, and other applicable regulatory standards. Champion proactive… more
- Merck & Co. (Rahway, NJ)
- …or biotechnologyKnowledge of regulatory aspects of pharmaceuticals including GLP, GCP and GMPAbility to manage multiple projects, including budgets, contracts, ... Development, Biochemical Assays, Cell Culture Techniques, Communication, Detail-Oriented, Ethical Compliance , Functional Genomics, In Vivo Models, Leading Project Teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …raised by the study team, including serious quality incidents and serious breaches of GCP . The SDL is accountable for escalation to the OPL/Asset Lead (or Senior ... site/ country performance including serious quality incidents and serious breaches of GCP . Triage, resolve or escalate study issues /risk mitigations as per JOC/ESC… more
- Merck & Co. (North Wales, PA)
- …operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesPreferredField-based medical experienceResearch ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Unknown (San Francisco, CA)
- …bioanalytical assay platforms. The ideal candidate will have a strong background in GCP , GLP, and GCLP compliance , and experience in supporting biomarker ... operations for registrational studies and regulatory filings. Exceptional organizational, communication, and stakeholder engagement skills are also a must. Hiring Manager Title Head of Biomarkers and Clinical Pharmacology, WCH Travel Percent Less than 10%… more
- Genmab (NJ)
- …the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange ... and processes Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data… more
- Eisai, Inc (Shreveport, LA)
- …career evaluation, coaching, mentoring, performance management and talent review. Ensure compliance with regulatory and other ethical guidelines relevant to the ... pharmaceutical industry, and to ensure compliance with Eisai policies & procedures and standard operating...a thorough understanding of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory/ethical guidelines relevant to the… more
- Merck & Co. (Boston, MA)
- …datasets is desirable.Experience with cloud-based computing platforms (eg, AWS, GCP , or Azure).Experience integrating imaging data with additional modalities ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …(TPP) development, due diligence projects, and clinical-regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design ... and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study… more
- The Computer Merchant, LTD. (Waltham, MA)
- …maintain a robust security architecture across 's cloud infrastructure in Azure, AWS, GCP , as well as its large PaaS and SaaS footprints. You'll proactively identify ... of security risks to deliver continuous improvement initiatives and to ensure compliance with industry regulations and best practices. You'll also combine excellent… more
- Reed Smith LLP (Pittsburgh, PA)
- …Engineer - Infrastructure is responsible for supporting the security and compliance of the firm's infrastructure, including networks, servers, workstations, and ... and in use across both on-premises and cloud environments, ensuring compliance with firm and industry security standards. Secure cloud environments (including… more
- Remington Medical Inc (Texas City, TX)
- …Sales Team to implement and execute strategies to achieve corporate objectives. Ensure compliance with all federal, state, and local regulations as well as clinical ... of medical terminology, clinical procedures, and healthcare regulations (HIPAA, FDA, ICH- GCP ) Documented track record of successful sales quota achievement Excellent… more
