- Merck & Co. (Rahway, NJ)
- Job Description Responsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis /modeling datasets, tables, listings, figures… more
- Merck & Co. (North Wales, PA)
- …patients and global human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early ... then transform the data into analysis datasets for further statistical analysis and reporting needs. The senior programmer will partner with statisticians… more
- Merck & Co. (Rahway, NJ)
- …studies, including development strategy, study design, initiation, execution, monitoring, analysis , regulatory reporting , and publication.Specifically, the ... applications, clinical study reports, or publicationParticipation in internal and joint internal/ external research project teams relevant to the development of new… more
- Merck & Co. (Boston, MA)
- …study design, medical monitoring, and medical/scientific interpretation of study analyses,- regulatory reporting , and publication.-The individual will apply an ... Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting , Scientific… more
- Cipla (Fall River, MA)
- …documents are up to date and correctly implemented. Assist in the collection, analysis , and reporting of quality data (eg, quality metrics, CAPA (Corrective ... Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals Inc. Fall River...QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA, ). Maintain and ensure the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …governance of global forecasts, ensuring compliance with internal policies and external regulatory requirements.Lead audit readiness and respond to governance ... owning demand and revenue forecasts for several oncology assets and will be reporting to the Senior Director, Global Business Strategy and Analytics. Director is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner ... standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics,… more
- Twist BioScience (South San Francisco, CA)
- …the accuracy of revenue reporting for both management (internal) and external reporting purposes.Manage and synthesize large datasets related to revenue and ... Company's revenue accounting policies and procedures, ensuring compliance with all regulatory requirements and SOX controls.Prepare ad-hoc revenue analysis ,… more
- Merck & Co. (Rahway, NJ)
- …New Product Development, Pharmaceutical Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation, Regulatory ... cell-line platforms. This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be… more
- Genmab (NJ)
- …CDISC standards and other industry standards that supports the exchange of data, reporting , and analysis . Ensures alignment of SDTM standards with data ... development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications… more
- Merck & Co. (Rahway, NJ)
- …gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution practices.- - Able to ... Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology) Reporting into the Director Packaging Distribution, Components and Systems… more
- Insmed Incorporated (San Diego, CA)
- …team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Clinical Development, you will support and work ... will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will be used to support key projects like Medical insights Mining, Care Gap Analysis , Medical Affairs Impact and Omnichannel strategy. This is a global role which ... identify and leverage synergies across analytics teams.Responsibilities- Data-Driven Insights Reporting and trend analytics: Lead the development and implementation… more
- Insmed Incorporated (NJ)
- …Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and ... Operations, Regulatory , and Clinical Development, as well as with external vendors. Oversees contractors and coaches junior team members.What You'll Do: Leads… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for leading company response from Deal to Contract (includes pre-deal assessment/ analysis , development of business cases for Pricing Committee, offer development, ... contract development, negotiation, pre-deal forecasting and reporting of contract profitability of customer segments for all Novo Nordisk products (diabetes,… more
- Merck & Co. (North Wales, PA)
- …written, oral, and presentation skills.Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, ... quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.Be… more
- Cipla (Fall River, MA)
- …Support initiatives aimed at improving overall productivity through data analysis and performance reviews. Develop and maintain strong professional relationships ... end-user requirements. Maintain clear and effective communication with internal and external stakeholders to address issues, facilitate smooth operations, and ensure… more
- Cipla (Central Islip, NY)
- …supplier management, and logistics. experience in materials/parts purchase, data analysis , reporting , and providing strategic insights, vendor negotiations, ... analyse PR-PO conversion reports, open order reports, and customized spend analysis reports to track and improve procurement processes. Identify opportunities for… 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
- Cipla (Hauppauge, NY)
- …standards. Represent facility and engineer to communicate with internal and external stakeholders. Provide consistent, complete, and timely feedback, project status ... Maintain departmental compliance pertaining to departmental SOPs, periodic review and reporting of the environmental monitoring system. Generate, review, approve and… more
