- Repligen (Waltham, MA)
- …desirable.Experience:A minimum of 10 years of progressive experience in internal controls, SOX compliance , or related regulatory compliance roles within a ... OverviewRepligen Corporation is seeking a dynamic Controls & SOX Compliance leader. This is a high-impact, strategic role driving global compliance ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and guidance to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and industry standards concerning ... and Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative...preferred. Basic QualificationsMust have 10 or more years of professional experience in Quality, IT compliance and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory ... for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned,… more
- Eisai, Inc (Raleigh, NC)
- …to Eisai.Ability to provide strategic vision to organization around increasing compliance and reducing costs.Experience developing and leading professional staff ... SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other… more
- Merck & Co. (Durham, NC)
- …a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing ... standard operating procedures that impact the efficiency and effectiveness of own unit. Compliance - Creating and sustaining a culture that ensures that compliance… more
- Merck & Co. (North Wales, PA)
- …analyses on programs. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody ... drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical… more
- Merck & Co. (Rahway, NJ)
- …Leadership Mentoring, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Social ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… 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 span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. - The incumbant is responsible… more
- Merck & Co. (Boston, MA)
- …tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory … more
