- Aequor (Parsippany, NJ)
- …Complete Medicaid analyzes and documentation on assigned states/programs. Communicate to manager for key findings and changes to state programs.10% Provide backup ... Complete Medicaid analyzes and documentation on assigned states/programs. Communicate to manager for key findings and changes to state programs. 5%Education… 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)
- …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)
- …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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... associated with clinical supplies for their assigned studies, which could vary in complexity. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serves as the GCS spokesperson at clinical… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational… more
- Merck & Co. (Rahway, NJ)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... the-Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will partner closely with key business stakeholders, the product, engineering, data science and other IT teams, to leverage advanced computational modeling and simulation tools to… more
- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product, and its approved indications,...for all accounts.Communicates on a regular basis with District Manager , internal and co-promote peers and discuss issues and… more
- 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)
- …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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... complete programming solution in the above area. The individual will be responsible for implementing new technological solutions for end users.The Associate Director, Clinical Programming manages and oversees JReview and SAS program development for clinical… more
- Merck & Co. (Rahway, NJ)
- …Company. This position reports to the Demand and Capacity Management Product Manager . A partial list of responsibilities includes the following: Define and implement ... integrations to systems and solutions that meet business requirements.Communicate with all stakeholders, including internal and external developers, end-users, product line/product owners and architects. Update stakeholders on the status of product development… more
