- Merck & Co. (North Wales, PA)
- …of drug therapy as outlined in the OR planning process and generates data on a worldwide basis to support pricing and reimbursement.Develops value evidence ... dossier, health economic evaluations) and their adaptation to generate country-specific data supporting pricing and reimbursement.Works closely with the VT team… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead.-- ... scientific discipline required.Required Experience and Skills:10 years experience and expert knowledge of USDA governance requirements.-Knowledge of international GMPs/… more
- Lundbeck (State College, PA)
- …LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be successful ... Planning & Account Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics, allocate resources to… more
- Merck & Co. (North Wales, PA)
- …Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new ... of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. The… more
- Merck & Co. (North Wales, PA)
- …teams to build value evidence strategies and tactics using input from data & analytics, Integrated Account Management, Outcomes Research and other stakeholder ... access for our ophthalmology portfolio. -The Director will be a subject matter expert on US health care ecosystem, interconnectivity of private and public payors,… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies of our company's and Competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. --The ... Clinical Reporting, Clinical Research Management, Clinical Trial Development, Communication, Data Analysis, Decision Making, Drug Development, Ethical Standards, Evidence-Based… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …GLP-compliant studies conducted at CROs; review protocols, monitor studies, and interpret data .Serve as the primary toxicology subject matter expert for ... interactions with regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, immunogenicity, insertional… more
- Carnegie Mellon University (Pittsburgh, PA)
- …institutions. With ground-breaking brain science, path-breaking performances, creative start-ups, big data , big ambitions, hands-on learning, and a whole lot of ... You will govern a complex portfolio of sponsored awards, providing expert guidance to Principal Investigators and department administrators. This position requires… more
- Airlite Plastics (Nazareth, PA)
- …reduce costs, and increase productivity. This routinely involves analyzing data , conducting experiments, and implementing new technologies or methodologies. *Develop ... teams to ensure that safety, quality, and efficiency expectations are met. *Analyze data using Statistical Process Control (SPC) and Six Sigma tools to achieve… more
- CSL Behring (King Of Prussia, PA)
- …all members of the cross-functional CDT acting as the lead scientific expert for the clinical program, while ensuring appropriate functional representation in team ... (TALT). + Leads the integration of internal and external expert contributions to strategy and design of the assigned...and external meetings. 3 Document Authorship: + Reviews the data generated during the planning and execution of a… more
- Greene Tweed (Lansdale, PA)
- …Tweed. **Essential Duties/Responsibilities** : + Serve as a subject matter expert on assigned applications. + Provide technical administration by partnering with ... for continual system alignment with business objectives + Configure and support data integrations by domain including third party connectors + Manage the Production… more
- Tunnell Consulting (Berwyn, PA)
- …compliance of all QC documentation, including test records, analytical reports, and data packages for a client-sponsored program. The QC/Analytical SME will provide ... subject matter expertise in analytical testing, data review, and GMP documentation practices. QC SME partners...analytical methods and SOPs. Act as QC subject matter expert for analytical testing and documentation review in a… more
- United States Fleet Forces Command (Philadelphia, PA)
- …effective conduct of production and engineering practices. Experience applying expert professional knowledge of engineering concepts, theories, principles, practices ... castings and fabrications. Experience interpreting and evaluating engineering drawings/specifications/technical data packages. Experience executing and understanding results of all… more
- CSL Behring (King Of Prussia, PA)
- …Team (CDT) Leadership: + Leads the integration of internal and external expert contributions to strategy and design of the assigned clinical program(s). + ... Team (SMT), the Benefit-Risk Assessment Team (BRAT), the Biomarker Expert Team (BET), and the Evidence and Access Strategy...and external meetings. 3 Document Authorship: + Reviews the data generated during the planning and execution of a… more
- Wipfli LLP (Radnor, PA)
- …product or solution. They are acknowledged internally and externally as an expert and are responsible for developing cybersecurity and IT infrastructure solutions ... relevant areas of expertise to address client challenges. + Maintain expert -level awareness and understanding of Microsoft Modern Workplace (Microsoft 365, Security,… more
- Carnegie Mellon University (Pittsburgh, PA)
- …institutions. With ground-breaking brain science, path-breaking performances, creative start-ups, big data , big ambitions, hands-on learning, and a whole lot of ... intelligence / machine learning (AI/ML), high-speed communications, and large-scale data storage for unclassified research. Our work drives discoveries across… more
- Organon & Co. (Plymouth Meeting, PA)
- …Description** **The Position** The Associate Director, Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of drug ... the drug product life cycle, including interpretation of relevant dissolution data . The scope includes small molecules and biologics/biosimilars, simple and complex… more
- CSL Behring (King Of Prussia, PA)
- …US Disease Area (DA). You will serve as the medical and scientific expert and represent current US medical practice to internal CSL Behring stakeholders. You ... ensure promotional materials are developed with fidelity to the data and scientific language calibrated to the appropriate audience....generation + Be the US lead scientific and clinical expert in the assigned disease area. + Provide input… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …knowledge of study-specific documents. **Job Duties** + Act as the Subject Matter Expert and primary point of accountability and reconciliation for the Trial Master ... + Supports literature search activities as required. + Ensures data quality by reviewing completeness and accuracy of study... quality by reviewing completeness and accuracy of study data , including facilitating the resolution of data … more
- CSL Behring (King Of Prussia, PA)
- …KRI) and determine any changes, additions and deletions. Supports the collection of KRI data twice per annum providing subject matter expert (SME) support for ... inputs into risk training for all the functions. You will act as a risk expert and key business partner in advising the risk leaders, risk experts and other business… more
