- Merck & Co. (North Wales, PA)
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the form of advice and recommendations to internal stakeholders Supports the analysis and implementation of pending and new regulatory requirements for US ... as Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations.… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including study design, initiation, execution,-monitoring, analysis , regulatory reporting , publication, and presentation ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… 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
- Eisai, Inc (New York, NY)
- …discipline (eg, AI/ML modeling, precision medicine). Proven experience presenting at external forums and influencing regulatory authorities. Strong people ... specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner… 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. (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
- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …to define product strategy, drive continuous discovery, and work with internal and external stakeholders to deliver high value product solutions that improve how we ... run clinical trials and regulatory submission for our patients, partners, and colleagues.As a...data driven decision making and clear communication.Value Measurement & Reporting Define success metrics (KPIs, OKRs, outcome measures) in… 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
- 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
- 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
- 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
- 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 (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
- 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 ... EHS controls in mind. Manage incident investigation, root cause analysis , and corrective action implementation. Develop and deliver EHS...as a liaison with regulatory bodies and external contractors/vendors. Drive continuous… more
