- Merck & Co. (Durham, NC)
- …Quality Control, Process Improvement Projects, Process Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Safety Management, Six Sigma, ... will be responsible for aligning maintenance projects with the business objectives around Safety , Compliance and Cost.- The Senior Mechanical Services… more
- Eisai, Inc (Seattle, WA)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology… more
- Merck & Co. (Durham, NC)
- …department systems, procedures and ways of working with a focus on safety , current Good Manufacturing Practices (cGMP) compliance and efficiency.Define ... successful candidate should be able to examine an issue from diverse perspectives ( safety , compliance , automation, equipment, process, and people) in order to… more
- Merck & Co. (Durham, NC)
- …implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety , and environmental regulations.- Actively ... and approve automation documents, preventive maintenance, and SOPs to ensure compliance with-Good Manufacturing Practices-and safety . Leads investigations of… more
- Merck & Co. (Rahway, NJ)
- …highest regard for all of our Company divisional and local site procedures for safety , quality, and regulatory compliance - Understand the big picture, and ... Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with… more
- Merck & Co. (Rahway, NJ)
- …opportunities across many diverse areas including Biological, Chemical, Automation, Safety , Technical Services, Process Development, Analytical, Regulatory , and ... execution against accelerated timelines, in a right-first-time manner, with a " safety first, compliance always" mindset.-Minimum Required Education and… more
- Merck & Co. (Millsboro, DE)
- …environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote best ... Job DescriptionSr. Specialist, Biosafety The Sr . Specialist of Biosafety is accountable for providing...Environment organization, and reports to the Associate Director of Safety & Environment at Millsboro, DE.Responsibilities:Ensure compliance … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory ... other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Novo Nordisk Inc. (Durham, NC)
- … compliance related activities Facilitate sharing of regulatory & compliance expectations Follow all safety & environmental requirements in the ... also be responsible for the production activities & validation. Ensuring relevant compliance issues are addressed & handled in close collaboration with production.… more
- Merck & Co. (Rahway, NJ)
- …Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Key ... Job DescriptionThe Director/ Principal Scientist, Regulatory Affairs Liaison , is responsible for the...functions:Reports to Senior Principal Scientist ( Senior Director) and/or Distinguished Scientist (Executive Director) Works Independently… more
- Aequor (Thousand Oaks, CA)
- …Maintain list of expected terms in the auto label tool Monitor the compliance of autolabel tool updates (if applicable) Support and lead Quality Assurance of ... employees and vendor staff (if applicable) on ICSR medical review Participate in Safety Assessment Team (SAT) if applicable Perform other duties related to the… more
- Merck & Co. (Rahway, NJ)
- …within the functional area; guide career development; build strong, collaborative teams.Champion compliance and safety while promoting a culture of diversity, ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our company's Research Laboratories (is committed to… more
- Merck & Co. (Rahway, NJ)
- …within the functional area; guide career development; build strong, collaborative teams.Champion compliance and safety while promoting a culture of diversity, ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… 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 development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Merck & Co. (North Wales, PA)
- …projects. Develop and execute statistical analysis and reporting deliverables (eg, safety and efficacy analysis datasets, tables, listings, figures), the span of ... which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Design and maintain statistical datasets… more
- Merck & Co. (Rahway, NJ)
- …with United States and European Union Good Manufacturing Practice (GMP) and Safety compliance regulations.Must possess ability to convert new drug product ... facility.Contribute to equipment and facility design, system commissioning/ qualification, regulatory certification, as well as other workstreams' critical activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinating and prioritizing CoE resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across the DS ... and senior leadership accountabilities in CoELead a team of safety physicians and scientists by recruiting, developing, and retaining talent; coach, mentor,… 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. (Rahway, NJ)
- …actively share expertise; guide career development; build strong, collaborative teamsChampion compliance and safety ; promote a culture of diversity, inclusion, ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
