- Merck & Co. (Rahway, NJ)
- …arms within the business.- - Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all ... the Company development products and non-Company marketed products. Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and… more
- Merck & Co. (Rahway, NJ)
- …Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic and operational plans associated ... and distribution for Clinical Finished Goods (CFGs) - Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares,… more
- Genscript USA Inc. (Piscataway, NJ)
- …performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility Engineer will provide high-level technical oversight ... lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals… more
- Merck & Co. (Rahway, NJ)
- …with applicable USDA regulations/ guidelines, customer requirements, SOPs and project specific guidelines/ instructions.Evaluate audit findings and ensure timely ... health authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer , compliance officer, other GMP/regulatory role or Site Quality Head… more
- ValSource, Inc. (Rahway, NJ)
- …equipment, etc. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required ... conduct Risk Assessments and Impact assessments, and establish system boundaries Generation, Review , and editing of Standard Operating Procedures. Review and… more
- Merck & Co. (Rahway, NJ)
- …main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… more
- Merck & Co. (Rahway, NJ)
- …activities performed by external partners.Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, ... milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.)… more
- Merck & Co. (Rahway, NJ)
- …updates to templates. The successful candidate will be expected to: Review , draft and/or develop legal documents and communications independently. Independently ... wide array of legal documents. Screen requests for legal advice/support, and review information provided from client for completeness, as needed. Respond to… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical, project , and people management responsibility. - This SSO Facility Lead role within the SSO ... and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendor related activities in Patient Safety including, but not limited to contract review and vendor management support in regard to safety reporting. To serves as ... initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, management of SDEA requirements, and supplier… more
- Merck & Co. (Rahway, NJ)
- …group of statistical or programming staff assigned to a development project as needed. More specifically,-Develops, coordinates, and provides biostatistical support ... under the 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… more
- Merck & Co. (Rahway, NJ)
- …including coordination with internal stakeholders and external advisors, (ii) review and determine optimal structure for various business development transactions, ... Management Office, and (iv) provide support for the preparation and review of legal documents related to business development and integration transactions.Accounting… more
- Merck & Co. (Rahway, NJ)
- …requests from the business and procurement. Typical Activities : Contract review /negotiations; PO issue resolution; creation of new vendors; supplier issue ... meetings with business partners and suppliers in connection with Target; review , analysis and negotiation of contracts pursuant to Target; data gathering/analysis… more
- Merck & Co. (Rahway, NJ)
- …party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed ... team accountable to deliver on priorities.Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing reports,… more
- Merck & Co. (Rahway, NJ)
- …Present compelling scientific business opportunities to senior leadership in governance review meetings. Contribute to the business development strategy of partner ... Drug Discovery Development, Executive Presence, Immunoassays, Precision Medicine (PM), Project Prioritization, Self Motivation, Strategic LicensingPreferred Skills: Current Employees… more
- Merck & Co. (Rahway, NJ)
- …sterile testing laboratories. Demonstrated ability in leading teams and talent development. Project management skills. Ability to work in a team environment with ... the laboratory for internal and external audits. Leads microbiological investigations Review and approval of data and reports. SOP development. Quality System… more
- Aequor (New York, NY)
- …reported outcomes strategy in a clinical trial setting Literature review and evidence synthesis. Supporting cost-effectiveness analyses and economic modeling. ... Developing presentations and reports utilizing PowerPoint and Excel. Project and vendor management including budget management support. Collaborating with… more
- Formation Bio (New York, NY)
- …strategic input to and monitor the execution of clinical studies as a project physician.Your ability to understand and navigate the complexities of healthcare data ... to develop deal models through your experience in clinical development Based on review of the scientific landscape contribute to therapeutic areas strategy Based on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Daiichi Sankyo's mission by leading conversations across functional teams (ie Grant Review Committees) around the grant and/or project decisions that meet the ... Internal Strategy and Operations- In alignment with senior colleagues, collect, review , and make decisions in collaboration with relevant Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the ... quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data… more
