- Genmab (Monmouth Junction, NJ)
- …of pharmaceutical industry regulatory development activities. Experience with document management system, authoring templates (Acumen) and publishing process ... Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group....and change errors in format. Working knowledge of electronic publishing/ document management system. Document all… more
- Merck & Co. (North Wales, PA)
- …curious, join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across the ... support OPS (Operations, Processes, and Strategic Execution) Policy Execution and the regulatory strategy of digital health tools (DHTs) and software medical devices… more
- Aequor (Thousand Oaks, CA)
- …the job description and be able to speak to why they want to work in regulatory affairs/ CMC. This was a big miss on the last posting. Pre screening responses from ... what do you understand this role to be?The Associate Regulatory Affairs (CMC) role is an entry level ... repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested. What we… more
- Aequor (Thousand Oaks, CA)
- …using computer software such as MS Office (ie, Excel, Word, Project), LIMS, document management systems, regulatory application systems, etc. Experience ... subject matter expert of clinical and commercial product stability studies and GMP data management . In this team-based role, you will directly add to the success of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Cycle Management , will be accountable for the authoring and lifecycle management of all GCO-owned procedural document packages, ensuring they are clearly ... package or any needed procedural document and/or procedural document package update(s). Cross-Functional Procedural Management Related to Vendor Alliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within the laboratory. Take the lead in managing Equipment Lifecycle Management processes, including overseeing change control procedures. Document and ... in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. Role Overview… more
- Christus Health (Johnson City, TX)
- …button below after reading through the entire description.Summary:The Utilization Management Nurse III is responsible for determining the clinical appropriateness ... and efficiently manage a diverse workload in a fast-paced, rapidly changing regulatory environment and are responsible for maintaining current and accurate knowledge… more
- Eisai, Inc (NJ)
- …MS project and MS Word and Experienced in the use of a document management system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the ... clinical and submission documentation across all aspects of the compounds' life cycle management , with support from management as needed. The qualified candidate… more
- Aequor (Collegeville, PA)
- …Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams Project management and/or continuous improvement experience or ... Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of 's dynamic investigational product portfolio.… more
- Novo Nordisk Inc. (Boulder, CO)
- …forms (injectables) preferred Experience with Veeva Vault or similar electronic document management system preferred Strong attention to details, organizational ... Collect and maintain monthly product quality metrics data for QA Management Maintain systems used for tracking various GMP manufacturing associated support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance ... with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the document archive.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize medical ... delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …instrumentation, and computerized systems.Knowledge of quality systems including exception management , change control, document control.Knowledge of operating ... documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and CDR rules,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and ... PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's… more
- Merck & Co. (Durham, NC)
- …to ensure project progress and milestone success.Responsible for effective document review, approval, and conformance to our Company Manufacturing Standards,-our ... and uses this knowledge in own work.Understands and applies regulatory / compliance requirements.FUNCTIONAL EXPERTISE:Our Digital Manufacturing Operations Senior IT… more
- Santander Holdings USA Inc (Everett, MA)
- …testing, Operational risk modeling, capital calculation and Knowledge of banking regulatory environment and impact on risk, management practices. Demonstrated ... part of the Compliance Analytics team which is responsible for overseeing risk management strategies to prevent, detect and disrupt usage of Bank products and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Contributes to regulatory authority requests or ... disorders. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety… more
- Merck & Co. (Boston, MA)
- …effectively troubleshoot issues, propose solutions for workflow improvements, and document best practices, including the authorship of Standard Operating Guidelines ... activities Upon invoicing, verify project deliverables with initiating scientist and document status in audit-compliant manner, prior to triggering payment approvals… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current training modules… more
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