- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the submission dossier, where applicable, and to ensure timelines and business objectives are met. Subject matter expert ( SME ) in 2 or more focus ... (DMCs) and due diligence activities for assigned product(s), as neededActs as audit/inspection Subject Matter Expert ( SME ) for safety surveillance… more
- Merck & Co. (Rahway, NJ)
- …on technology-related business problems, leveraging IT colleagues as appropriate. Acts as subject matter expert on CTSM solution, primarily responsible ... team member in the deployment and support of- SAP applications across all functional areas supporting Clinical ...on with full Life Cycle Implementations with emphasis as Subject Matter Expert in SAP.-… more
- Merck & Co. (Rahway, NJ)
- …to evolve. Develops subject matter expertise within functional and technical teams in overall SAP solutions for Clinical and provides direction and ... team member in the deployment and support of SAP applications across all functional areas supporting Clinical ...business problems, leveraging IT colleagues as appropriate. Acts as subject matter expert on Supply… 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
- Merck & Co. (North Wales, PA)
- …and SOPs, and supports/oversees functional or cross-functional networks of process owners/ subject matter expertsAdherence to GCP, local and global policies ... as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with Quality… more
- Tris Pharma (Monmouth Junction, NJ)
- …member of Senior Leadership, she/he serves as a Subject Matter Expert ( SME ) regarding Pain specific clinical development and provides strategic ... throughout development lifecycle of projects to build trust and confidence in company’s Clinical and Medical process Serves as SME on pain therapeutic space;… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …life cycle management. Briefs senior management on assigned projects or studies as needed. Subject matter expert in multiple therapeutic areas.CRO / Vendor ... for the function. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional… 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
- Aequor (Thousand Oaks, CA)
- …you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP ... new roads for helping patients. Key Responsibilities include: Build and maintain technical GMP documents and product stability studies Review, verify, report, and… 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
- 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
- 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
- Preferred Solutions Group (Bethesda, MD)
- …graphics to be used by the Federal Task Leader. . Serves as NIH search policy subject matter expert for assigned DIR laboratories and search committees. . ... the ability to work in a high stress environment. Technical Requirements . Assist in developing and coordinating science...and research effort. . Plan and evaluate scientific and clinical research programs and initiatives. . Develop and evaluate… more
- Sutter Health (Livermore, CA)
- **Organization:** SSL-Sutter Shared Lab-Bay **Position Overview:** Functions as the technical and clinical subject matter expert in one or more areas ... Special Chemistry, Hematology/Coagulation, Urinalysis and Transfusion Service. + Demonstrates subject matter expertise in one or more technical areas of the… more
- Ricoh Americas Corporation (Jacksonville, 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
