- Novo Nordisk Inc. (Plainsboro, NJ)
- …to draft FDA meeting requests and supporting briefing packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory ... roles. Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA,… 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
- 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 ... to GCS and serves as the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product development related meetings . The… 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) ... requirementsCoordinate with broader DS quality teams to support GRA meeting company policies for quality management (eg, completing requests/initiatives from… 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 ... serves as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program CSPM designs strategic and operational plans… 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)
- …provide programming supports in agency response or potential Advisory Committee Meeting - Develop and maintain programming macros to effectively support internal data ... review and monitoring. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basisQualifications: Successful candidates will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to resolution. Leads supplier relationship management to ensure suppliers are meeting expected performance levels and driving innovative ideas for potential Brand ... methodologies are understood and utilized. Serve as the lead "relationship manager " to deliver best practices to the business partners.Leads supplier relationship… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Orders (PO's) and ensures that CMO's and internal DS plants are meeting DSI supply needs across the entire product portfolio.ResponsibilitiesManage the development ... of all packaging plans for CMO's based on forecast and current inventory levels across all product portfolios. Manage the creation of production plans for finished goods. Analyze inventory trends and procure bulk drugs and finished goods. Coordinate efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preparing meeting logistics, distributing agendas, and minutes for study team meeting , meetings with Academic Research Organizations (AROs), and meetings ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations for both in-house and outsourced studies.- ... vendor contract and MSA discussions, strategic vendor selections, and bid defense meetings .- Provides laboratory data expertise and guidance to the program teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …VP of Finance & Supply Chain. Reporting into this position are the Senior Manager - Financial Transactions; Director - Accounting & Fin Controls, and Director - US ... financial statements and other materials as requested for Board of Directors meetings for NNI and US Holding Companies Provides input and influence concerning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from ... training and preparing the technical team, to authoring and finalizing the meeting minutes. This position develops awareness of global requirements through support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations according to cGMP requirements.Lead the daily start of shift operations meetings , the daily wrap up production meetings and assign individuals ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… 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)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to ... the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health AuthoritiesGlobal BDO Strategy to Improve Drug… more
- Merck & Co. (Rahway, NJ)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk-based… more
- American Express Global Business Travel (Trenton, NJ)
- …for sharp fluctuations which may impact the budget. + Assist in review of other Meeting Manager budgets. Work on special projects as assigned by team leadership. ... supports as a primary client liaison and lead for executive/board level meetings for global pharmaceutical client. Work closely with client contact to understand… more
- The Conference Board (New York, NY)
- Meetings Manager Apply Now! Back to search Location: New York, NY Department: US Events Posted: 5/1/2025 Location Name: New York, NY Wage Max: 60,000.00 Wage ... information and the specific accommodation needed. Position Summary: The Meetings Manager play's a critical role in...Manager play's a critical role in providing high-quality meeting and events experiences for The Conference Board's valued… more
- American Express Global Business Travel (New York, NY)
- …and account management experience with prior meeting & events background.** The Strategic Meetings & Events Manager is an innovative leader at Amex GBT ... strategies to drive incremental revenue through a combination of increased meetings , premium product revenue, advisory consulting, supplier relations initiatives and… more
