- GRAIL (Durham, NC)
- …for supporting the maintenance, delivery, and continuous improvement of GRAIL's Records and Document Management , Systems, and Education- with an emphasis on the ... Address, respond-to, and complete NCRs, CAPAs, and Internal/External Audit Findings associated with document management needs and gaps. + Generate data for key… more
- Integra LifeSciences (Princeton, NJ)
- …and oversee quality and compliance improvement and remediation strategies for document and record control, change management , and training administration ... and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the...and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design,… more
- BeOne Medicines (San Mateo, CA)
- …partners **Computer Skills:** Proficiency in MS Office Suite applications and document management systems. All qualified applicants will receive consideration ... **General Description:** This role is the head of Promotional Regulatory , and provides regulatory leadership, support, oversight, and strategic guidance on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the management of ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence: Oversees the Management of PV Regulatory … more
- Merck & Co. (Lower Gwynedd, PA)
- …Culture Techniques, Clinical Judgment, Clinical Trials, Communication, Customer Experience Management , Data Analysis, Data Visualization, Detail-Oriented, Drug ... The PDMB Regulated Bioanalytics Department is seeking a Data Management Associate to join our LIMS & Data ...pivotal safety and efficacy clinical patient data required for regulatory filings. As the Advance facility will not be… more
- Merck & Co. (Millsboro, DE)
- … management and execution of critical quality systems such as change control, document management , Deviation management , etc. - Performs GMP walk through ... transactions required to release product. The role performs process document audits for accuracy and completeness and works in...to cGMPs and is knowledgeable in federal and other regulatory agency requirements and other regulatory agency… more
- Hargrove Engineers & Constructors (Conroe, TX)
- …Are** Hargrove supplies unparalleled services in engineering, procurement, construction management , and technical services in the industrial, commercial, and ... **Job Scope:** The E & I Engineer (Process Safety Management ) is generally responsible for performing all aspects for...(MOC) and Pre-Startup Safety Reviews (PSSR). Coordinate, conduct and document ad hoc PHAs as required for MOC and/or… more
- BeOne Medicines (Emeryville, CA)
- … system + Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (ie, Veeva) + Advanced knowledge of data mining ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
- Merck & Co. (Rahway, NJ)
- …matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Synterex (Boston, MA)
- …resources (eg, quality control [QC], publishing) Serve as an expert on client document management system and related tools, templates, and procedures to ensure ... desired Expertise with Microsoft Word and other Microsoft applications Familiarity with document management systems Ability to work both independently and… more
- Southland Industries (Garden Grove, CA)
- …will also be responsible for the supporting our customer's need around case management , legal document management , compliance tracking, risk assessment ... improvement of technology solutions for our **Legal and Risk Management ** departments. In this role, you will serve as...ensuring that systems are secure, efficient, and aligned with regulatory and operational needs. You will manage, support and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and...Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the … more
- Merck & Co. (North Wales, PA)
- …and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market ... can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical...need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … regulatory requirements, policies and guidelinesExperience with Quality Control document reviews and regulatory inspection processesWorking knowledge of ... NJ. Role OverviewThe QC Specialist, Lab Services is responsible for sample management . The QC Specialist is encouraged to work independently on routine tasks… more
- Stony Brook University (St. James, NY)
- …Capture and Reconciliation, Registration, Scheduling, Patient Throughput, Health Information Management , Electronic Document and Signature Capture, Visitor ... Management , online payment solutions, Document Imaging, Diagnostic Coding, Deficiency Management , and...(3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements… more
- Arvinas (New Haven, CT)
- …Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, ... On August 8 th 2025, the US Food and Drug Administration (FDA) accepted the New Drug ...will collaborate with Clinical Operations, Translational Sciences, Clinical Pharmacology, Regulatory , Research and other functions within Arvinas, as well… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- …collaborative projects and develop subject matter expertise Knowledge of order management , supply chain operations and document control #eligibleforERP ... clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Mission Support and Test Services (Mercury, NV)
- …maintaining thorough documentation, leading projects, ensuring compliance with regulatory standards, and expertly managing risks. Furthermore, effective ... and objectives, perform personnel administration activities including performance reviews, performance management , and appraisals. + Be the point of contact in the… more
- Caris Life Sciences (Phoenix, AZ)
- …Initiation Visit meeting and offer ongoing site support. + Liaison with study sites and regulatory document team to ensure regulatory documentation is up to ... **Position Summary** A Clinical Trial Specialist-Biorepository provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma… more
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