- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with cross functional areas including: Commercial, Safety, Medical, Clinical Operations , and Legal. This structured approach will allow for… more
- Merck & Co. (North Wales, PA)
- …the prevention and treatment of diseases. We are seeking an Epidemiology Study Manager to support our Lead Epidemiology Scientists in the coordination and execution ... publicationsUnderstand, coordinate, and document adherence to internal, external, and regulatory compliance requirementsCollaborate and troubleshoot issues by providing potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business stakeholders ... development, implementation, and maintenance of software systems that support business operations and objectives, with a special emphasis on HCP engagement systems.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the ... in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/Clinical BiomarkersSupport clinical study teams and functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... to maximize your potential with us? The Position Responsible for managing day-to-day operations of pharmacy programs. This person will be responsible for driving new… more
- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). Responsible for project management of the ... Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of the portfolio… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions, including market trends, competitive dynamics, patient needs, and regulatory requirements. Stay abreast of industry developments, emerging technologies, ... demonstrated history in portfolio management, indication sequencing, or business operations or related roles Strong understanding of pharmaceutical product… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments). Partner with the Study Manager on study deliverables. Ensure CRF design supports data collection in alignment ... clinical drug development . Must possess solid knowledge of clinical research regulatory requirements (eg, GCP and ICH); ability to manage multiple competing… more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... sample management operations in support of routine GMP operations ...support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of the LBRI Office of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… 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 OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments,… more
- Merck & Co. (Durham, NC)
- …support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.- Responsible for establishing ... and approve BOM changes and Master Batch Records. Review and approve Operations , Technology, or Automation protocols. Leads or actively participates in project suite… more
