- Tris Pharma (Monmouth Junction, NJ)
- …procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration ... strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety ... position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy...and Health Administration (OSHA), and Drug Enforcement Agency (DEA)… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.--This position serves as a senior… more
- Merck & Co. (Rahway, NJ)
- …cGMP, Safety & Environmental Policies and Procedures.Familiarity with Capital Project systems ( administration and execution) as well as Computerized Maintenance ... and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation for qualified equipment/ systems (audit trails, user groups, system administration )Provide expertise and solutions to issues regarding ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Eisai, Inc (Indianapolis, IN)
- …hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ... C-suite, administrative stakeholders, key influencers, and decision-makers within health systems ) within the market place.Collaborate with regional leaders and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Merck & Co. (Rahway, NJ)
- …Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.-- Job descriptionThis position will be… more
- Eisai, Inc (Exton, PA)
- …focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production ... be responsible to maintain and/or enhance the production area systems and technology to remain compliant with regulations and...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
- Eisai, Inc (Nutley, NJ)
- …strategy for global MA/MSL training that is personalized, integrated with Eisai systems , and data-driven.Support new hire MSLs scientific training via didactic and ... desired therapeutic area(s); comfortable and confident speaking about multiple drug indications/disease state management and competitor products and data.Understanding… more
- Eisai, Inc (Louisville, KY)
- …broad-based scientific and pharmaceutical knowledge.Clinical trial development and drug launch experience is strongly preferred.Knowledge of treatment guidelines, ... Eisai organization, including as it pertains to compliance with policies, systems and practices.Sound computer skills including applications for word processing,… more
- Eisai, Inc (Phoenix, AZ)
- …and safety messaging and information about product access / safe administration to relevant customer stakeholders in a compliant way.Monitor operating costs ... regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food, Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ Guidance;… more
- Eisai, Inc (Nutley, NJ)
- …guidelines.Direct program level oversight of Clinical development plans (CDP) and drug development Plans (DDP) for marketed products as well developmental compounds ... and requests for study related information.Strong knowledge base of the drug development process.Deep knowledge of the specific therapeutic area.Proven track record… more
- Eisai, Inc (Boston, MA)
- …and safety messaging and information about product access / safe administration to relevant customer stakeholders in a compliant way.Monitor operating costs ... regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food, Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ Guidance;… more
- Eisai, Inc (Bakersfield, CA)
- …knowledge. Presentation skills, teaching skills, and confidence in discussing drug information/ disease state management. Prior experience in clinical research, ... drug development and/or clinical pharmacy and a basic understanding...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
- Eisai, Inc (Nutley, NJ)
- …Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as ... disabled veterans.Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the… more
- Veterans Affairs, Veterans Health Administration (San Antonio, TX)
- …appropriately credentialed to prescribe medications before entering them into the system . Follows facility policies to enter/review Prescription Drug Monitoring ... and appropriateness using acceptable pharmacy practice standards. Enters Prior Authorization Drug Requests (PADRs) into electronic health record system as… more
- Veterans Affairs, Veterans Health Administration (Syracuse, NY)
- …safe working environment. This includes not limited to Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), United ... all purchases. Download invoices daily as part of the drug accountability process or other inventory management system...maintenance including: Generic and brand names Dosage forms Various systems of weights and measures Drug product… more
- Kelsey-Seybold Clinic (Houston, TX)
- …radiology departments. Coordinate required annual physicist inspections, Food and Drug Administration inspections, TDH inspections and preventative maintenance ... MRI units. **Job Title: MEDICAL IMAGING QUALITY SPECIALIST- Radio - Administration ** **Location: Main Campus** **Department:** **Radio - Administration ** **Job… more
- Veterans Affairs, Veterans Health Administration (Memphis, TN)
- …to the standards required by multiple accrediting agencies (eg Food and Drug Administration , The Joint Commission, the National Fire Protection Association, ... The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for… more
