- Tris Pharma (Monmouth Junction, NJ)
- …stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals. ESSENTIAL FUNCTIONS Assists and ... in pre and post marketing environments Expert knowledge on Food and Drug Administration (FDA) safety regulations, International Conference on Harmonisation (ICH)… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The ... Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees… more
- Catalent (Philadelphia, PA)
- …good manufacturing practice/quality system requirements of the Food and Drug Administration , state boards of pharmacy, European, South American, Japanese, ... System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. Other… more
- Tris Pharma (Monmouth Junction, NJ)
- …needed and/or licenses or certificates preferred:Experience working with Food and Drug Administration (FDA), International Council on Harmonisation (ICH) ... These include but are not limited to: method improvements, system equivalency, transfers, verifications, alternate source qualifications and authoring residual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference ... with internal Functions within the study team to ensure drug destruction process and other study close out activities...a regular basis.Assist or Lead training SOPs, GCPs, operational systems , etc.The supervisor should coach and guide their direct… more
- Merck & Co. (North Wales, PA)
- …company policies and guidelines, particularly those that relate to Food and Drug Administration (FDA), Accreditation Council for Continuing Medical Education ... vendors who partner with the Innovation and Emerging Projects team on key systems -Is core member of the Digital Team (D-Team). Provides project management to D-Team… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) requirements Provides technical Subject Matter Expert ... Develops and maintains packaging specifications and standards; Analyzes existing packaging systems and recommend modifications; Designs and prototypes new packaging … more
- Tris Pharma (Monmouth Junction, NJ)
- …needed and/or licenses or certificates preferred:Experience working with Food and Drug Administration (FDA), International Council on Harmonisation (ICH) ... activities include, but are not limited to: method improvements, system equivalency, transfers, verifications, alternate source qualifications and authoring residual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference ... information in all data management activities, databases and tracking systems .Company Sponsored Studies (CSS) and Medical Access/Expanded Access Program… more
- Tris Pharma (Monmouth Junction, NJ)
- …(SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements. ESSENTIAL FUNCTIONS Primary ... the pharmaceutical or biotechnology industry Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs Hands… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position ... developing sterile products for injectable, ophthalmic, and inhaled routes of administration . Support both early and late-stage development candidates that will… more
- Insmed Incorporated (Bridgewater, NJ)
- …requirements.Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).Proficient with System Administration of analytical software such as Waters ... associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. The… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... You'll experience a broad range of responsibilities spanning study administration , client communications, revenue recognition, and ensuring on-time delivery of… more
- Yakima Valley Farm Workers Clinic (Cowiche, WA)
- … including Microsoft Office preferred. Basic knowledge of at least one pharmacy software system with ability to learn new ones. Drug testing: This position ... patient care services as assigned, which include but are not limited to: Drug Utilization Review Patient Counseling Drug Regimen Review Medication Therapy… more
- Merck & Co. (Rahway, NJ)
- …of relevant experience. Required Experience and Skills: Experience with converting new drug substance process needs to an executable series of steps and procedures ... to enable acceptable product manufacture. Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to… more
- Yakima Valley Farm Workers Clinic (Lake Oswego, OR)
- …name, insurance, allergies, doctor and diagnosis. Enters the prescription in the system , selecting the brand, product/ drug , and appropriate strength to align ... with The Joint Commission (TJC), Health Resources and Services Administration (HRSA) and YVFWC requirements. Qualifications Education: High School...Basic knowledge of a minimum of one pharmacy software system and ability to learn new systems .… more
- Jazz Pharmaceuticals (Boston, MA)
- …for establishing, building, and managing business relationships within health systems and community oncology practices with key stakeholders, ensuring access ... and maximize resources with strategic oncology accounts. (Community, Health Systems and large Channel Accounts).Lead the development of account-level strategic… more
- Merck & Co. (North Wales, PA)
- …- DayValid Driving License:NoHazardous Material(s):N/ARequired Skills:Benefits Administration , Management System Development, Product ... events. The data collected from Clinical Trials are used to support drug applications and regulatory submissions to health authorities globally.Trial Data Management… more
- Duke Health (Durham, NC)
- …support certifications per required.-Can provide the following therapy:-Oxygen Supply Systems Equipment Processing Manual Resuscitation Oxygen administration ... and accuracy.-Understand pharmacological indications, dosages and response to adverse drug reactions.-Consults with providers based on patient care assessments and… more
- Eisai, Inc (Nutley, NJ)
- …corporate objectives. Advanced understanding of clinical research and the clinical drug development process Advanced understanding of the Neurology or Oncology ... therapeutic areas Advanced understanding of the drug development plans, preclinical toxicology, toxicology, CMC, regulatory and other development requirements as… more
