- Aequor (Seattle, WA)
- …Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting. ... Job Description: Top Skills: - 2&plus years of Document Control & Reporting Experience, - Veeva experience...technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles… more
- Catalent (Manassas, VA)
- …track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and verify the operators' ... to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for...join Catalent : Defined career path and annual performance review and feedback process Potential for career growth on… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions… 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
- Insmed Incorporated (Bridgewater, NJ)
- …such that all components are provided and presented in the correct format.Manage document review and approval as needed.Assists with other projects to support ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review ... clinical studies - CTD submissions/Others - May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will also provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in...in Raritan, NJ. Role Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities… 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
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management functions for all NNI internet sites Manage PRB (medical, legal, regulatory) review of NNI internet site and its waterfall of content Manage project ... and tactical sign off prior to implementation Healthcare Professional Website Management: Document all web development and content publishing processes in an SOP and… more
- Kolmac (Baltimore, MD)
- …the training and development of all clinical staff. The Clinical Operations Manager (COM) is responsible for managing Key Performance Indicators and staff ... for ensuring compliance with Kolmac/CCG policies and procedures. The Clinical Operations Manager (COM) has responsibility for the execution of the long and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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...Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the … 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
- 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
- Kolmac (Columbia, MD)
- …provider in the Mid-Atlantic region that is seeking a full time Clinical Operations Manager (COM) in person in our Columbia, MD location working a combination of a ... title of this position will be COM~ Clinical Operations Manager ) The Clinical Operations Manager (COM) at...for all sessions/groups, performance management/annual evaluations as well as review of and approval of timecards and any other… 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
- Aequor (New Brunswick, NJ)
- …of a project. This Project Coordinator will be assisting with the review of the existing Project Lifecycle Management process, coordinating modifications and ... publish/report defined metrics data relating to project attributes. Assist the Project Manager (PM) in coordination of information to support the project design and… more
- BLOSSOM RIDGE HOME HEALTH AGENCY LLC (Sacramento, CA)
- …and discharge Oasis for the home care patient. *Observe, assess, and document symptoms. *Monitor reactions and patient progress. *Educate patients and caregivers on ... *Notify the physician and other personnel (DPCS, PT, Case Manager ) of change in the patient's condition. *Perform skill...or without reasonable accommodation, to enable the employee to review a wide variety of materials in electronic or… more
