- Merck & Co. (Rahway, NJ)
- …as appropriate and per timelines.Contributes to CRA team knowledge by acting as process Subject Matter Expert ( SME ),-buddy/mentor and sharing best ... technical information effectively.-Good understanding and working knowledge of clinical research, phases of clinical trials,-current GCP/ICH & country… more
- Tris Pharma (Monmouth Junction, NJ)
- …initiatives/projectsManages, coaches and mentors a small team of direct reports Serves as a Subject Matter Expert ( SME ) and provides medical/scientific ... patient needs. We have more than 150 US and International patents (including applications ) and have marketed several branded and generic products in the US, have… more
- Catalent (St. Petersburg, FL)
- …on existing clients/products that have opportunities for improvement. Is expected to become the Subject Matter Expert for the client products, processes and ... to Master Batch Records; Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment,… more
- Lundbeck (Bothell, WA)
- …SOPs, development reports, and technical reports In partnership with QC, serve as the Subject Matter Expert ( SME ) in the transfer of analytical ... the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a...transfers, qualifications and validations and ultimately serving in a Subject Matter Expert role. Key… more
- Aequor (South San Francisco, CA)
- …of safety and efficacy endpoints. Serve as a subject matter expert and implementation lead for application of open-source R and python Client modeling ... presentation of past work for 45min. The Computational Biology group in the Clinical Biomarkers & Diagnostics (CBD) department at is seeking a highly motivated Sr… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Maintains current knowledge of industry best practice in AI/ML methodology- May act as Subject Matter Expert for AI/ML by providing guidance and support ... applications and best practices as well as strong technical skills in working with ( clinical ) data. The position holder will require strong skills in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits. Supports Quality risk assessment teams. Review/approve documents as a Quality on the Floor Subject Matter Expert ( SME ). Remain current in skills ... oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes… more
- Tris Pharma (Monmouth Junction, NJ)
- …evaluate and communicate safety observations. The incumbent functions independently as a subject - matter expert ( SME ) while working collaboratively ... (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study Reports (CSRs), etc.); Provides expert safety guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data standards and data cleaning needs for DS Programs / Studies.Serve as the subject matter expert for Study Data Managers during the planning/start-up, ... (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skillsfor integrating and importing external data received from...Clinical trial data systems and/or EDC and related applications is a plus. Daiichi Sankyo, Inc. is an… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide ... and investigations within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …submissions, including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), ... marketing authorization applications (MAA), and new drug applications (NDA) Clinical study protocols and protocol amendments Clinical study reports (CSR)… more
- Catalent (St. Petersburg, FL)
- …Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and ... is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated… more
- Insmed Incorporated (Bridgewater, NJ)
- …ensuring the continued refinement and enhancements of the manufacturing process.Responsible for technical support as Insmed's internal SME , technical review ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Merck & Co. (Rahway, NJ)
- …the following:The automation engineer role at the Specialist level will serve as technical SME and capital team member supporting the Modality Agnostic Chemistry ... individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position… more
- Insmed Incorporated (Bridgewater, NJ)
- …must possess a good understanding of pharmaceutical development processes from pre- clinical development through life-cycle management. This position will also manage ... for lab consumable purchases. This will include authorship, review, and approval of technical documents such as qualification protocols and SOPs as well as the… more
- Catalent (St. Petersburg, FL)
- …and procedures for control systems, automation, analytical equipment, and IT applications .Ensure that GxP systems comply with all applicable GxP, legal, and ... provide guidance, training, and support to site personnel.Participate as DI SME in deviation management investigations, CAPA, and effectiveness check processes for… more
- CHRISTUS Health (Lindale, TX)
- …with these in healthcare practices and activities. Standard V. Leadership Serves as a subject matter expert for patient care Gives continuing feedback, ... recognizes achievement, and recommends improvement as a patient care subject matter expert . Supports proper allocation of team resources, delegates… more
- CHRISTUS Health (Tyler, TX)
- …these in healthcare practices and activities Standard V. Leadership Serves as a subject matter expert for patient careGives continuing feedback, recognizes ... achievement, and recommends improvement as a patient care subject matter expert .Supports proper allocation of team resources, delegates appropriate levels of… more
- Ricoh Americas Corporation (Tampa, FL)
- ** Clinical Applications Specialist** **POSITION PROFILE** The Clinical Applications Specialist role is to promote and sell 3D anatomic modeling services ... design thinking to create novel solutions for them. To ensure success a clinical applications specialist will create and maintain an extensive sales network… more
- Henry Ford Health System (Troy, MI)
- …of care. GENERAL SUMMARY: The Senior Clinical Application Analyst serves as a subject matter expert in one or more applications ' capabilities and ... clinical strategic goals. PRINCIPAL DUTIES AND RESPONSIBILITIES: + Subject matter expert ( SME ) in one or more applications ' capabilities and… more
