- Merck & Co. (Rahway, NJ)
- …of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. Mentors ... and the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager ( Program CSPM)...(ie Bulk Drug Product). Oversees all bulk drug supply management and ensures proper allocation of drug product as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director can be an extension to the Asset Lead when needed and serve as an SME ( Subject Matter Expert ) on applicable Study Managment processes. He/she ... immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program (s). Provides managerial...as needed/required at GPT and meet with stakeholders to support the larger program or their group… more
- Genmab (NJ)
- …of external data collection standards, and providing SDTM mapping guidance Serves as a subject matter expert on all aspects of standards development that ... implements company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/ program ...integrity Directly supports knowledge development of others as a subject matter expert on data… more
- Columbia Technology Partners (Annapolis Junction, MD)
- …and produce final reports Develop security guidance for a variety of IT subject matter areas Participate in medium to large complex information and ... by applicable employment laws and regulations. All applicants and employees are subject to random drug testing in accordance with Executive Order 12564. Employment… more
- Insmed Incorporated (NJ)
- …analysis efficiency, identifying ways to enhance the system where needed and acts as the subject matter expert on the systemWho You Are: Bachelor's degree in ... Sets tasks, prioritization, and resources within assigned compound(s) Provides program -level programming leadership and support to clinical development… more
- Insmed Incorporated (NJ)
- …working independently with minimal supervision.What You'll Do: Significant scientific contributor and subject matter expert in preparation of clinical ... Medical Writer is a REMOTE position, responsible for the development and management of medical writing deliverables, including but are not limited to protocols… more
- Insmed Incorporated (NJ)
- …deliverables.Communicate and counsel Insmed senior leadership on HEOR strategic priorities.Collaborate as a subject matter expert on HEOR and a strategic ... marketing, medical affairs, and clinical development to understand and support Insmed's business needs. This is a global role.What...external partners (regulators, HTAs, payers, providers, patients) as a subject matter expert on Insmed's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Brand teams and Global Communications. This position serves as a consumer social media subject matter expert and collaborates with all areas within USO ... program , focusing on identifying, training, and managing internal subject matter experts to build digital authority...to build digital authority and trust Serve as the expert on social media channel performance, risk management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …integrated into operational processes and compliant with industry standards Serve as a subject matter expert on GxP documentation requirements, providing ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …requirements. This roles also serves as the subject matter expert in providing guidance, oversight and project management of assigned projects in ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....make a difference? The Position The Manager PS Case Management is responsible for the management of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …manager up to date on progress and ensures no surprises, and is seen as a subject matter expert in today's complex healthcare landscape who is sought out ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that require reviewing multiple factors to determine proper resolution, with management support as needed. Demonstrated problem solving skills, creativity, ... ensure local process compliance. Acts in role as process SME for the Deviation process at USO. Support...manner which meets their expectations. Quality Assurance Provides secondary support to all USO Quality Management processes,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …CROs; review protocols, monitor studies, and interpret data.Serve as the primary toxicology subject matter expert for interactions with regulatory agencies ... functions such as Pharmacology, CMC, Regulatory Affairs, Clinical, and Program Management .Maintain up-to-date knowledge of evolving regulatory guidelines… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case processing issues and provides support and escalation ... expert guidance to cross-functional teams regarding safety case management activities Process Development & Optimization Design, implement, and continuously… more
- ExxonMobil (Baytown, TX)
- …dental, and vision plans. + Culture of Health: Programs and resources to support your wellbeing. + Employee Health Advisory Program : Provides confidential ... **What you will do** + Provide innovative, value-added product and application support for Basestocks technologies + Identify and champion new business opportunities… more
- Tunnell Consulting (Berwyn, PA)
- …analytical reports, and data packages for a client-sponsored program . The QC/Analytical SME will provide subject matter expertise in analytical testing, ... offices in Washington DC, and Boston. We are seeking support of a Quality Control / Analytical SME...to approved analytical methods and SOPs. Act as QC subject matter expert for analytical… more
- Insmed Incorporated (NJ)
- …and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, perform risk assessments for supply interruptions and ... operational excellenceOversee global depot inventory, labeling strategies, temperature excursion management , import/export logistics, and ensuring patient supply continuityWho You… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … expert guidance to cross-functional teams regarding safety case management activities Process Development & Optimization Oversees medical review of individual ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of case handling… more
- Applied Research Solutions (Bedford, MA)
- …and operations oversight. + Provide engineering support services and inputs to program and project risk management activities in compliance with Air Force ... procedures. Analyze and/or evaluate results of major engineering systems. + Provide system/ program engineering, technical support and technical training to … more
- Post Holdings Inc. (West Jefferson, OH)
- …Schedule & days could flex for business need.** The Aseptic Processing SME Maintenance Lead (APSMEL) provides both maintenance and reliability services within the ... plant operational team, equipment suppliers, and all other plant support teams members for success. This position will work...The APSMEL will manage and lead the plant PSM program , always ensuring regulatory compliance. This position has the… more
