- Insmed Incorporated (NJ)
- …collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and ... for the management and oversight of global phase I-IV clinical trials, with a key focus on Ph2b-3, from...(CST Leads), as assigned.This role can be hybrid or remote .What You'll Do: Leads and coordinates the management and… more
- Insmed Incorporated (NJ)
- …one compound to ensure all are delivered on time, within budget and with high quality . This role may manage clinical operations team members, as delegated by ... the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents Clinical… more
- Eisai, Inc (Tampa, FL)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies. Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in… more
- Merck & Co. (Rahway, NJ)
- … Clinical Trial Operations (GCTO) Regional colleagues and Global - Development Quality (GDQ) to address clinical supply related topics. - Responsible and ... supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. - Responsible and… more
- Merck & Co. (Rahway, NJ)
- …internal and external R& D collaborations to enable innovative strategies for clinical trial biomarker testing. Author and review internal technical reports ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers into clinical development across all therapeutic areas and all phases of … more
- The Joint Commission (Oakbrook Terrace, IL)
- …Field Representatives, with minimal direction or supervision, survey and/or review health care organizations throughout the United States. Field Representatives ... **Responsibilities** Position Accountabilities: + Ability to analyze and synthesize survey/ review findings to provide conclusions, recommendations and educational opportunities.… more
- Insmed Incorporated (NJ)
- … clinical programs. Represents medical writing on cross-functional teams.Produces high- quality and timely documentation in line with expectations. Interprets and ... preferred. Clinical /Regulatory medical writing experience is requiredMust demonstrate a high- quality writing style in the English language and have the ability… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training… more
- Merck & Co. (South San Francisco, CA)
- …data science, while focusing on uncovering novel biology that delivers high- quality drug discovery pipeline.-We are a research-driven biopharmaceutical company. -Our ... a team of scientists in the research of metabolic diseases & obesity. Review and seek out potential external research collaborations and licensing opportunities to… more
- Parexel (Des Moines, IA)
- **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a remote role !_** **Position Purpose:** The Clinical ... Quality Operations Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head...periodically (eg quarterly) perform a Therapeutic Area (TA) level review of quality plans and risk mitigation… more
- Merck & Co. (Rahway, NJ)
- …team of microbiologists whose roles include executing analytical methods to release clinical drug substance and drug product and support both non-sterile and sterile ... manufacturing.- This role contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable, which involves the development of robust chemical and… more
- Merck & Co. (Rahway, NJ)
- …ensuring the integration of internal subject matter expert input and the quality of formal due diligence output. Work closely with transaction leads, legal, ... Present compelling scientific business opportunities to senior leadership in governance review meetings. Contribute to the business development strategy of partner… more
- Merck & Co. (Rahway, NJ)
- …and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal ... strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s)… more
- Genmab (NJ)
- …experience.Supports high- quality clinical trial conduct and relationship quality through ongoing review , identification and resolution of issues and ... teams and relevant stakeholders to obtain in-depth requirements to support efficient review of the conduct, quality and integrity of the… more
- Merck & Co. (VA)
- Job Description- The-Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and ... health care providers such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. Within their geography there… more
- Insmed Incorporated (San Diego, CA)
- …regulations, regional guidance documents and ICH guidance documentsRegulatory writing and/or review of documents supporting product development and clinical ... to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program… more
- Lyra Health Inc (Searcy, AR)
- …studies, and delivered unmatched outcomes in terms of access, clinical effectiveness and cost efficiency. Extensive peer-reviewed research confirms Lyra's ... through Lyra Empower, the only fully integrated, AI-powered platform combining the highest- quality care and technology solutions. About the Role Lyra is committed to… more
- HealthCare Support (Houston, TX)
- …HealthCare Company in Remote Houston TX . Daily Responsibilities for Utilization Review RN: WIll need to use their OWN EQUIPMENT: 2 screens, will need a ... MAC or any other seem to work fine) 1. Review telephonic and faxed clinical information to...for cases reviewed within established turnaround times. Meets established quality standards 7. Actively contributes to achievement of departmental… more
- Insmed Incorporated (NJ)
- …NJ headquarters. This is a hybrid role that offers a blend of on-site and remote work opportunities. As a Packaging Engineer at Insmed, you will play a crucial role ... The individual will conduct packaging development projects from initiation through clinical and commercial manufacture (launch & beyond). Projects will consist of… more
