- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... submission and submission related documents in the Company's electronic document management system (EDMS).ResponsibilitiesRESPONSIBILITIES:Support regulatory submission activities… 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
- Aequor (Thousand Oaks, CA)
- …Delivery teams and suppliers Develop and maintain Project Sourcing Plan with Project Manager as a \"living document \" throughout project life cycle Lead ... for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and… more
- Merck & Co. (North Wales, PA)
- …integrity of study data for reports and publicationsUnderstand, coordinate, and document adherence to internal, external, and regulatory compliance ... Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group members.Training… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... prescribe data handling, protection, and user provisioning controls- Identify, assess, monitor, document , and communicate potential quality issues in the way data is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the authoring and lifecycle management of all GCO-owned procedural document packages, ensuring they are clearly and effectively written and maintained, ... Management:Responsible for the ownership and maintenance of GCO-owned procedural document packages.Lead authoring, review, and periodic reviews/updates for all GCO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the document archive.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... 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)
- …analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... by providing input for the interaction or by writing the interaction document . May participate in meeting or teleconferences with Health Authorities Qualifications:… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- The Document Control Team is hiring an Manager ! As the Associate Manager , Document Control, you will lead and supervise Document Control operations ... of system improvements + Acts as the voice of Document Control the site in manager 's meetings...overall efficiency and effectives of our systems + Oversees document logistics room during regulatory and partner… more
- Kelly Services (Portland, OR)
- …hire. **Workplace:** OnsitePortland, OR **Overview** Position Overview: The Documentation Control Manager is responsible for overseeing and managing Document ... Kelly(R) Science & Clinical is seeking a Documentation Control Manager for a direct hire opportunity with one of our clients, a leading natural foods company in… more
- Bristol Myers Squibb (Trenton, NJ)
- …skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, ... graphical displays + in compliance with BMS documentation standards and worldwide regulatory requirements + Participate in relevant document subteam(s) and… more
- Amentum (Richland, WA)
- Title Closure Regulatory Manager Position Number 39142 Company WA River Protection Solutions City/State Richland, WA Location Richland, WA Posted 06/19/2024 ... within the Hanford SST tank farms. As the Closure Regulatory Manager , reporting to the group ... and-or technical documentation to meet HFFACO requirements, conduct document research as required, support document reviews,… more
- KPMG (Dallas, TX)
- **Business Title:** Manager , HR Document Management **Requisition Number:** 112065 - 87 **Function:** Business Support Services **Area of Interest:** **State:** ... are, join our team. KPMG is currently seeking a Manager , HR Document Management to join our...and records, while also ensuring compliance with legal and regulatory requirements pertaining to document retention, privacy,… more
- Lauridsen Group Inc. (Ankeny, IA)
- …systems for high-quality submissions to regulatory health authorities. + Coordinate regulatory document collection and inspection and audit needs for product ... The Senior Manager of Regulatory Affairs plays a...regulatory submissions and facility registrations/renewals per QMS and document management policies. + Keep updated with regulatory… more
- Editas Medicine (Cambridge, MA)
- …the way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring ... registration, and commercialization of our products. Key Responsibilities: As the Senior Manager , Regulatory Affairs, you will be responsible for: + … more
