- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews ... initiatives for development activities / programs post internal system audit.Support reporting of quality metrics for audits and inspections and execute against… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and AI toolsWorks closely with the site to gather data and reporting requirements and aligns tools/models/reportingWorks in collaboration with Validation function to ... in driving consistent statistical approaches and defending them to regulatory authorities is desirableExperience in collaborating with internal technical SMEs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identify and leverage synergies across analytics teams.Responsibilities- Data-Driven Insights Reporting and trend analytics: Lead the development and implementation ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a...required- 4 or More Years Experience with dashboarding and reporting tools like Tableau, Power BI and Looker required-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …path forward for manufacturing issues.Real time review of all documentation, and reporting , in support of process unit operations, in accordance with Good ... will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. ... resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of a rapidly expanding, commercialized CAR-T product portfolio. This position will be reporting to Head of Global Sourcing and will develop and execute a long-term ... with Quality, Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare alternate/secondary sourcing strategies.Achieve cost savings objectives for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe Associate MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing ... Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget ... risk management to teams.Experience with Healthy Authority requirements and regulatory submission activities preferred.#DD1#OnsiteThe anticipated base pay range is:$107,482—$141,070… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget ... project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent knowledge… more
- Genscript USA Inc. (Piscataway, NJ)
- …for site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency drills. Serve ... risks. Ensure compliance with OSHA, EPA, and other applicable regulatory agencies. Conduct risk assessments, hazard analyses (eg, JHA,...as a liaison with regulatory bodies and external contractors/vendors. Drive continuous improvement in… more
- Tris Pharma (Monmouth Junction, NJ)
- …monthly, quarterly and annual consolidated financial statements; Assists with regulatory reporting , as applicableResearches and corrects accounting issues ... support in ensuring company financial records remain accurate while meeting reporting deadlines. The incumbent establishes and approves internal controls and… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication. -- Responsibilities: Specifically, the ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , and publication.Specifically, the Senior Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Public Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key relationships in NN/AS ... opportunities; and works with reporters to ensure accurate media reporting Leads communications excellence activities that contribute to leadership development… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Merck & Co. (Rahway, NJ)
- …operational support and ensuring the smooth functioning of our procurement processes. Reporting to the Global Capital Procurement PMO Lead, the Specialist will ... with PO and invoicing issues, manage expedited payment requirements per regulatory requirements Contractor Invoice Management : Process purchase orders for… more
- Merck & Co. (Rahway, NJ)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
