- Twist BioScience (South San Francisco, CA)
- …Qualifications Experience with vendor management and the implementation of the corporate safety program Experience with Environmental Health & Safety ... of site to ensure compliance with local health and safety regulations Model company safety policies and...local health and safety regulations Model company safety policies and participates in Emergency Response Team efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including program business rules, SOPs, systems used (including CRM, Safety system and PSP dashboarding tools), exceptions processes, workflows, scripting and ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing ... at least one therapeutic area or a large, global Phase 3/4 program .This position identifies and selects resources/tools to facilitate risk management during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ... cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Responsible for driving best in class solutions while driving budget and program efficiencies. This individual will maintain a high-level of collaboration and… more
- Insmed Incorporated (San Diego, CA)
- …and scientific support to clinical development and operations, regulatory, medical affairs, drug safety , and quality assurance teams, as well as overall program ... functional teams to develop and implement clinical studies within clinical program (s). Responsibilities include but are not limited to:Collaborate with internal… more
- Genmab (Plainsboro, NJ)
- …Clinical Research Scientist (as warranted).Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of ... Director, contribute to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... be responsible for leading the analysis and interpretation of patient support program data to drive strategic decision-making and optimize program effectiveness.… more
- Genmab (NJ)
- …area for one or more compounds Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical ... and regulatory documents and registration dossiers (ie, protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and… more
- Merck & Co. (Durham, NC)
- …of complex automated process equipment.Work compliance systems for maintaining PM program and assessing equipment - SAP, ProCal, DeltaV, Pi. Could include ... Hazardous Energy Control Procedures.Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines. Effective communication both written and… more
- Insmed Incorporated (San Diego, CA)
- …company at regulatory meetings including presentation at Advisory Committee Meetings.Preparing safety charters, DMC charters, or other specific management plans and ... experts to gather inputOrganize scientific advisory board meetings and data safety monitoring committee meetingsMaintain a high level of clinical and scientific… more
- Merck & Co. (Millsboro, DE)
- …animal facilities as well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly ... external regulatory inspections (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site… more
- Novo Nordisk Inc. (Boulder, CO)
- …This position interacts with Chemical Development, AD/QC, Engineering, Facilities, Program Management and QA. Essential Functions Accountable for the management ... for API manufacturing activities assuring the manufacturing resources comply to all safety , GXP, regulatory and business processes or procedures Ensure the operating… more
- Novo Nordisk Inc. (Durham, NC)
- …(DTCC), or a comparable post-secondary education institution's educational program (s), directly related to industrial maintenance. Industrial Maintenance Apprentices ... processes. Relationships Associate Manager, Maintenance Essential Functions Follow all safety & environmental requirements in the performance of duties Learn… more
- Aequor (Devers, TX)
- …maintains the area in a clean and orderly fashion.Recognizes and reports safety , maintenance, and operational variances to area management.Communicates the status of ... detailed SOPs and batch records.Ensures compliance with cGMP and safety requirements.Maintains files, records, and equipment.Records data, logs activities, and… more
- Merck & Co. (North Wales, PA)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Manager II is responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job Responsibilities:Manage large-scale, complex projects or multiple ... effective communication.Provide executive-level communication and reporting on project and program performance. Prepare and deliver presentations to key stakeholders.Drive… more
- Merck & Co. (North Wales, PA)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key collaborator with statistics and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety , therapeutic area leads, MSLs etc.) across the US and Canada. ... training programs related to GxP, Clinical, Medical and Regulatory affairs, Patient Safety required A thorough understanding and proven track record in the following… more
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