- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will be ... process capability to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …passion for digital transformation.Familiarity with digital tools such as data analytics platforms, workflow automation technologies, and change management ... communication, stakeholder management, and project coordination skills.Demonstrated ability to lead cross-functional teams in a matrixed environment with strong… more
- Merck & Co. (Rahway, NJ)
- … Data Product Management role, you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving ... team of highly talented individuals working on multiple data products and use cases, providing thought leadership and...to drive results and enable their success.Specific responsibilities include: Lead team to manage life cycle of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations ... stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Genmab (Plainsboro, NJ)
- …across various markets within cancer treatment.We are now looking for a Clinical Project Lead (CPL) to join the team , who will be responsible for oversight ... Responsibilities Include:Serve as core member of the Compound Development Team (CDT) representing Development Operations.Provide input into the Clinical and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …through business development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, ... future. The Position The purpose of the Speaker programs lead is to advance knowledge in the rare disease...working collaboratively with the Rare Disease Enterprise and Influence team to ensure strategic market education initiatives align with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …through business development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, ... shaping our future. The Position The Rare Disease Conventions Lead plays a pivotal role in advancing knowledge and...contributor to the Rare Disease Commercial Strategy and Marketing team . Responsible for providing interface with key internal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... projects for CDO and/or as part of a global team and as aligned to a business case, goals...developing others is required - shown ability to indirectly lead and direct teams We commit to an inclusive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implement successful product plan. Helps to shape strategy and culture within their team . Relationships Reports to Rare Bleeding TA Lead and is responsible ... drive a focus on a human-centric, insight-driven strategy Leverage data , insights and best practices to optimize brand performance...with the priorities of the business Recruit, build and lead a highly effective marketing team Physical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections in the US, in collaboration with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional ... assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in...and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information… more
- Merck & Co. (Rahway, NJ)
- …sources, or identifying partners to create needed assets, or enacting internal initiatives.Leads team in conducting data innovation analytics including data ... providers.- ` Qualifications: Overall, proven ability to build a data asset strategy & innovation agenda and lead...to inform critical commercial decisions and actions.Proven ability to lead a team in analyzing and assessing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure delivery of RBQM CSM Training with Learning and Development team members. Lead development and implementation of process improvement initiatives ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will interface with key stakeholders across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the ... (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Merck & Co. (Rahway, NJ)
- …be responsible for supporting marketing analytics in partnership with the business team , with particular focus on promotional investment optimization. As a Data ... quantitative and analytical skills to combine the art and science of data analytics and marketing to help business stakeholders address the complex challenges… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. ... Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across ... and initiatives, focusing on enhancing processes efficiency, culture permeation and team capabilities.The incumbent will bring a combination of technical expertise,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads… more
