- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Communication:- Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and ... review Statistical Analysis Plans (SAPs) and statistical outputs (tables,...assigned clinical studies- CTD submissions/Others- May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to post trial information on required public forums (eg.clinicaltrials.gov).Under supervision, review and document CRO-generated reports, such as site monitoring ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF document trackers generated by the CRO with the … more
- Merck & Co. (Rahway, NJ)
- …as needed. The candidate will also provide supports SCDM/LCDM in the creation and review of Trial Deliverables, document archiving, UAT of Data Bases, External ... (GDMS) within the GCTO organization. GDO focuses on data collection, data review and integrity throughout the lifecycle of clinical trials.-Clinical trials provide… more
- Insmed Incorporated (Bridgewater, NJ)
- …adhering to corporate policies and external regulations and guidance. The Manager , Scientific Communications & Publications, provides support to the Associate ... medical experts, investigators, publishers, and publication support vendors/agencies. The Manager , Scientific Communications & Publications drives the timely execution… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control, etc. The focus of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... the successful day-to-day operations of the Automation Engineering department.Generate, review , approve and control departmental documentation (eg, SOPs and system… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Job Summary The Manager , Data Programming & Reporting is a member of the Biostatistics and ... standard and exception data listings, and visualizations to support ongoing data review activities, achieve critical study milestones, and gain data insights into… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …CAPA-related activities in areas under management Responsible for initiation of document reviews, periodic reviews and documentation revisions as needed Provide ... moderate to complex scope, where analysis of situation or data requires review of identifiable factors. Exercises judgment within defined procedures and policies to… more
- Merck & Co. (Rahway, NJ)
- …reject product. Make independen t batch release or reject decisions. - Conduct auditing, review , and approval of diverse and complex document types, as required ... Global Development Quality Operations - API,- is responsible for review and approval of documentation to support Good Manufacturing...document approval. - Other duties as assigned by manager for the flexible functioning of the work group.… more
- Merck & Co. (Rahway, NJ)
- …product. Make independent batch release or reject decisions.-- Conduct independent auditing, review , and approval of diverse and complex document types, as ... Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance, and patient safety related to managing assigned clinical trials, document management and management of clinical trial management systems and archiving ... systems. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with external partners relevant to the planning and… more
- Merck & Co. (North Wales, PA)
- …advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, ... and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- DLA Piper (Washington, DC)
- …**Job Description Summary** DLA Piper seeks review attorneys for its internal Document Review Center. We are looking for candidates with prior electronic ... document review experience; prior experience in Relativity review ...Relativity, for responsiveness, privilege, and issue coding, communication to review manager regarding questions or issues with… more
- Astellas Pharma (Westborough, MA)
- …Westborough, MA site. This is an onsite position. **Purpose and Scope:** The Manager , Quality Assurance Document Control (QADC) role oversees the daily ... team responsible for administration of the cGMP Documentation program. This includes document issuance / reconciliation; SOP implementation, periodic review , and… more
- ICU Medical (Lake Forest, IL)
- Job Title Manager , Quality Systems - Document Control FLSA Status Exempt Position Summary The Manager , Quality Systems - Document Control reports ... directly to Senior Manager , Document Control and Training. This position will manage and...This position will manage and coordinate functional activities of document and record control, including periodic review ,… more
- CBRE (Sterling, VA)
- Associate Project Manager ( Document Control) Job ID 149922 Posted 09-Jan-2024 Service line GWS Segment Role type Full-time Areas of Interest Construction, ... Virginia - United States of America **About the role** + Overall, the Document Control Coordinator, ("DCC") shall support CBRE's client with the implementation of… more
- Fluor (Greenville, SC)
- …executing division or project assignments). This position may serve as the Office Quality Manager for a Major Execution Office or the Project Quality Manager for ... and qualified and follow up on audit findings and corrective actions * review of purchase orders and contracts for technical and quality requirement inclusion *… more
- SAIC (Washington, DC)
- **Description** **Innovation and Quality Project Manager (Project Management Office PM) Responsibilities:** **General Tasks:** + Manage assigned projects in ... and report on all activities. Work with SAIC and Document Operations ("DocOps") Team Leads to effectively track and...weekly basis. + Proactively notify the SAIC DocOps Program Manager with a level of urgency consistent with the… more
- US Bank (Waterloo, IA)
- …The Document Custody Services department is hiring an Operations Manager 1 that manages and coordinates the operational activities for assigned functional ... ensures compliance with applicable laws and regulations. Participates in the review and recommendation of operational systems and procedures affecting assigned… more