- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend ... New Jersey! We are looking for a dedicated and action-oriented Employee Engagement Manager to lead our engagement initiatives. In this newly created role, you will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... and manages a team of Oncology Territory Managers and is accountable for the compliant promotion of the assigned product with the assigned customers. This territory covers the following states NJ and Metro NY. Nature and Scope: Demonstrate Daiichi-Sankyo… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …methodologies are understood and utilized. Serve as the lead "relationship manager " to deliver best practices to the business partners.Leads supplier relationship ... management to ensure supplier performance meets expected services levels and drives and enables innovation for potential Brand application, and continuous improvement.Leads complex bid analysis, commercial contract negotiations, and execution, partnering… 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 ... Investigations will be part of the Operations Investigations team and will be responsible for managing and leading different investigations work-cells, drive investigations to closure, support escalations, monitor and improve performance metrics for team. They… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary:The Associate Director, Oncology Value & Market Dynamics Training Manager is responsible for developing & deploying a strategic training plan ... brand strategies. To ensure maximum effectiveness of customer facing teams, the manager will work proactively with internal stakeholders to lead the assessment for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on ... personnel performance.Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... technical responsibility (minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses or certificates… 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 skills, analytical, organizational, and interpersonal skills and works effectively with people at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads US FDA/EU EMA interactions with support from higher-level manager .Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves ... as RA CMC representative supporting company initiatives. Qualifications:Education and Experience: Bachelor's Degree in Life Science required.M.S./PhD. preferred in a scientific discipline. MS Degree with 8-10 years pharmaceutical industry experience with 4+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and disease-specific requirements to DM standards teams and program teams.- Advise Manager , Laboratory Data Management on complex textbook range and unit requests as ... necessary.- Provides laboratory expertise in the resolution of lab related inquiries and issues such as conversion factors, translations, and textbook ranges.- Approves the resolutions provided in the Local Lab FAQ log for Local Lab team discussion topics,… more
- Merck & Co. (Rahway, NJ)
- …Program Management and Execution Excellence. We are looking for a season Program manager with a passion for driving impactful business outcomes for our company. This ... role offers the opportunity to influence, mentor, and lead cross-functional teams while managing large-scale projects that span multiple divisions and groups. If you thrive in a fast-paced, agile environment and are ready to make a significant impact, we want… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to ... multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... and operational plans associated with the downstream activities of clinical supplies for their assigned studies.- The primary function of the IM CSPM is planning the availability of materials and subsequent movement through our depot network and further… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to set the direction for the entire organization. The Position The Senior Manager US Operations Strategy supports in the development and implementation of the US ... Operations Strategy. This includes driving key strategic projects, doing quantitative and qualitative analyses, engaging stakeholders across the business, and keeping updated with external and internal factors that impact our strategy. Relationships This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …roles. Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, ... Biologics, Devices) to government agencies in support of research and marketed products Create and maintain product/project database to record history of questions asked / responses received during FDA meetings Liaison between NNI and NNAS departments for… more
