- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of PV Regulatory … more
- Merck & Co. (North Wales, PA)
- …project progression, coaching on Company processes relating to CMC development team management , strategic document preparation, PM skills, and Team Management ... management -Experience with the planning and execution of strategies for drug product registration and commercialization / life-cycle management (can be… more
- Monster (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence: Contribute to the management of PV Regulatory … more
- Genmab (NJ)
- …MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Synterex (Boston, MA)
- …resources (eg, quality control [QC], publishing) Serve as an expert on client document management system and related tools, templates, and procedures to ensure ... desired Expertise with Microsoft Word and other Microsoft applications Familiarity with document management systems Ability to work both independently and… more
- Merck & Co. (Rahway, NJ)
- …matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Lower Gwynedd, PA)
- …Business Administration, Cell-Based Assays, Clinical Testing, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global ... including the biological sciences, computer sciences, medical technology, business management , etc.-Responsibilities-Strong knowledge of document or training … more
- Protagonist Therapeutics (Newark, CA)
- …of APIs. Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials, and drug substances that meet global ... production and process and related technology transfer to CDMOs and management of partnering CDMOs. Expectations Foster a collaborative culture interacting with… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Aequor (Thousand Oaks, CA)
- …document , investigate, and communicate decisions concerning distribution complaints. Sales Order Management : - Create and manage clinical drug shipments in ... go down and manual processes required. Experience with Quality Management Tracking Systems (QMTS) is preferred but not required...you will play a key role in ensuring clinical drug products are distributed globally to clinical sites, supporting… more
- Statistics & Data Corporation (SDC) (Waltham, MA)
- …statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project ... management with strategic planning, proposals, pricing, and timeline planning....protocol, as needed *Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study… more
- Merck & Co. (Durham, NC)
- …and implement process improvements.This position will support the purification of the drug substance of the vaccine.Responsibilities may include but are not limited ... to; Supports production activities in the manufacture of drug substance material. Works in conjunction with all appropriate personnel, performs manual and automated… more
- Ashley Furniture Industries, LLC. (Whitehall, WI)
- …Improvement Tools, national incident management system (NIMS) or emergency management systems and document management system Experience implementing, ... audits, job safety analysis and compliance with all standards related to regulatory bodies. This individual will assure compliance with the OSHA standard that… more
- Federal Transit Administration (Washington, DC)
- …Oversight (TSO), Office of Safety Oversight and Compliance (TSO-20), Safety Enforcement Drug and Alcohol Compliance Division (TSO-23). Serves as a liaison between ... Safety Oversight (SSO) program. Monitor SSOA's and RTA's compliance with regulatory requirements and enforcement actions. Inspection and coordination of safety… more
- Translational Research in Oncology (Los Angeles, CA)
- …sites status updates and common site trends to Monitoring Resources and Project Management Departments Oversee study drug management at clinical study ... clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, TRIO Standard Operating Procedures (SOPs), Standard Guidelines (SGs),… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …gets to work on this. You have strong knowledge of cGMP requirements. You document proposals to reach a solution with relevant stakeholders (eg QA, C&Q, Operations, ... CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems. You will also write SOPs (Standard Operating Procedures) and… more
- Monster (Marietta, GA)
- …manner Drug /Alcohol Testing: Drug /alcohol testing is required Drug /alcohol testing required per Non- Regulatory requirements for employees working with ... a high degree of walking in outdoor environmental conditions, excellent time management , and exceptional flexibility day to day. Great Pay & Bonus Potential:… more
- CytomX Therapeutics, Inc. (South San Francisco, CA)
- …finally utilization of an electronic Trial Master File (eTMF) and associated document management procedures. Job Responsibilities: Provide support to the ... comprises seven therapeutic candidates across multiple treatment modalities including antibody- drug conjugates ("ADCs"), T-cell engaging bispecific antibodies ("TCBs"), and… more
- Munchkin (Van Nuys, CA)
- …and customer specific requirements Establish and maintain process control including document management , factory certification audits, date coding product, sewn ... Assurance Engineer's primary responsibility is to assist with establishing the regulatory , quality, safety and reliability Company policies and procedures to ensure… more
- Monster (Tempe, AZ)
- …containment, ensures safe work environment Performs other duties as assigned by management and supervisors Additional Statements: Drug and alcohol screening: ... C ensuring a work environment that meets safety and regulatory standards for the client. You will be responsible...work accurately and in a timely manner) Strong time management and organizational skills Sound judgement; Good problem-solving and… more
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