- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) ... By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide vendor comparisons and award qualified vendors.Provide SME support for regulatory inspections and regulatory filings.Author/ Review /Approve documents ... Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Eisai, Inc (Exton, PA)
- …management that the controls they have implemented are being executed.The Senior Manager is responsible for providing guidance on GxP and validation process ... documentation overhead while maintaining the intended level of controls. The Senior Manager is responsible for supporting quality awareness efforts to ensure quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and changes to key stakeholders Stewards NovoCare.com work through the Promotional Review Process in collaboration with agency partners and Promotional Review ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory , and clinical processes Ensures timely execution and follow-up, meets… more
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... clinical supplies.-Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... increase investigations output while maintaining investigations quality. As needed, review investigations to ensure consistent quality standards are maintained.Responsible… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!Overview: The Programming Manager supports the development of new therapies by ensuring integrity, consistency and ... study or leading tasks within a study are in scope. The Programming Manager will work with other functions including Data Management, Statistics, Drug Safety,… more
- Merck & Co. (Durham, NC)
- …for a company-Durham Facility.Completion of tasks required to release batches such as DOM/SLED Review , QN and CR review , testing review , market restrictions ... collaborative meeting groups to support release on time release group needs.Author, review , and approve local release SOPs, assist with providing product related… more
- Merck & Co. (Durham, NC)
- …procedures, engineering design guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks, ... Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Operations Management team, ... shop floor leadership.- Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with a team of… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... a high performing statistics group to support translational medicine projects as a manager of at least 5 statisticians.Serve as a reviewer for the cross-functional… more
- Twist BioScience (South San Francisco, CA)
- …, Customer, and Twist requirements. In this position you will report to the QC manager .What You'll Be Doing Review and release products based on established QC ... process quality reports by collecting, analyzing, and summarizing information and trendsWrite/ review product quality documentationFollow regulatory and ISO 13485… more
- Novo Nordisk Inc. (Durham, NC)
- …addressed & handled in close collaboration with production. Main duties include review of batch reports & release of incoming materials, deviations, change controls, ... review & approval of SOPs, QA presence & process...floor & improvement of Quality processes. Relationships Reports to Manager , QA. Essential Functions Ensure plant systems batch release… more
- Aequor (Swiftwater, MN)
- …ability to work in a team environment, effectively interacting with others. Review current documents- incorporate comments from Manager . Navigate through Content ... guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with...Incorporate comments from team members and provide status to manager on review and approval workflow. Follow… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Novo Nordisk Inc. (Durham, NC)
- …Author & review documents in accordance with local, corporate & regulatory regulations Support &/or lead the closure of investigations per approved timeframes ... for projects according to science & risk-based validation (SRV). Relationships Manager , Process Support - OFP. Essential Functions Participate & provide feedback… more
