- Merck & Co. (Rahway, NJ)
- …proteins as well as the biopharmaceutic support for the oral and non -oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development ... be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record… more
- Merck & Co. (North Wales, PA)
- …supervision of management .-Lead a team of staff assigned to the project as needed.-This includes the following activities:1. Is involved in late clinical ... reports to effectively communicate results of clinical trials to the project team, Management , regulatory agencies, or individual investigators.9. Provides… more
- Merck & Co. (Rahway, NJ)
- …strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating resources for cross-product ... of initiatives to Product Lines and operational teams on project completion.Required Competencies:Proven experience in resource planning, cost estimation, and… more
- Repligen (Hopkinton, IA)
- …etc.)Working Knowledge of sampling plan(s).Requires verbal or written communication to management of all Non -Conforming Material.Reject any non -conforming ... is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for inspecting, auditing and reporting on… more
- Merck & Co. (Rahway, NJ)
- …for research and development projects (data, analyses, tables, graphics, listings)A project leader; completes tasks independently at a project level; ... and ADaM standardsDemonstrated ability to work in an exploratory environment, handling non -standard data in a variety of formats with minimal requirements; knowledge… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to lead as a change agent to promote flexibility, creativity, and accountability. Project management skills, responsiveness to issues, and demonstrated passion ... according to cGMP requirements.Lead a ~250+ organization responsible for either the non -sterile or sterile manufacturing processes in a 24/7 operation and be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This ... risks/quality drift in external vendor and NNI processes to mitigate non -compliance and deviation occurrence Support internal and external stakeholders with issue… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …function within the role of Quality Business Partner where requested by management Develops comprehensive, relevant resources (eg training program, FAQs) to enable ... risks/quality drift in external vendor and NNI processes to mitigate non -compliance and deviation occurrence Support internal and external stakeholders with issue… more
- Eisai, Inc (Nutley, NJ)
- …ROI measurements that will inform recommendations to optimize personal and non - personal promotional channels while developing and executing on a comprehensive ... Excellent communication and presentation skills, including experience with presenting to senior management and ability to explain complex concepts to a non… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Budget; Establishes effective communication between CRO / vendors / AROAdditional non -study related activities: Occasional senior management interactions at ... around rare diseases and immune disorders. Summary: Oversees typically a single non -pivotal trial (small size, standard complexity in design and geographic scope).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...Labeling members and Clinical members. This position works with non -standard problems of some complexity. This position makes decisions… more
- Aequor (East Syracuse, NY)
- …fast-paced, interactive, and entrepreneurial environment. Position is a team and project -based position that may require occasional shift work, weekends, and ... drug substance, and drug product samples. The candidate will execute non -GMP testing, non -GMP stability testing, reference standard qualification, and… more
- Merck & Co. (Rahway, NJ)
- …and/or epidemiologists within BARDS, as well as stakeholders in data management , medical writing, and clinical operations to gather and document requirements ... high quality and timely deliverables. Communicate and collaborate effectively with project team members.Education RequirementsMust have a master's degree in computer… more
- Repligen (Hopkinton, IA)
- …with multiple departments and associatesShares timely information with peers, Lead and/or Management on daily progressAbility to contribute to project teamsFocus ... is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the document control department… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and deliver a process platform is robust and consistent. Portfolio management is required to implement process improvements, optimization, capacity expansion, and ... cost of goods / non -conformance reduction efforts worldwide.Key Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to: support to manufacturing equipment projects, cost-improvement initiatives, asset management , reliability, and business operations.Support facility project ... electrical devices, circuits, and switchgear used in cGMP and non GMP systemsInvestigate, troubleshoot, and provide repairs to equipment, instruments,… more
- Repligen (Waltham, MA)
- …and board members.Strong technical accounting skills with expertise in M&A accounting.Strong project management skills, with the ability to manage multiple ... accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual filings (eg, 10-Q,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …valuations in order to provide strategic guidance to senior management , support commercial and strategic decision making.ResponsibilitiesRevenue Forecasting - Owns ... in line and pre-launch US products, both oncology and non -oncology. Leads the team to develop sophisticated short-term and...and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively… more
- Twist BioScience (South San Francisco, CA)
- …based on customer and market requirements; interact with diverse technical and non -technical groups at all organizational levels to delineate and solidify our ... the marketing budget and identify opportunities for maximizing ROI.Work with product management , digital marketing, and the regional teams to direct the creation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non -significant/significant risk determinations (both submission to CDRH in a Q-sub ... (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to...as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team… more
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