- Merck & Co. (Upper Gwynedd, PA)
- …and Skills: At least 5 years global or US medical affairs or clinical development experience with proven track record of contribution to medical or ... and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders....Brand and V&I Outcome Research Team leads to define clinical development plans and brand strategies for… more
- Merck & Co. (North Wales, PA)
- …and location strategies. Contributes to the strategic vision and optimization of Global Clinical Trial Organization. Education Requirements: BA or BS degree, ... Job DescriptionThe Associate Vice President, Global Data Management & Standards (GDMS)...Standards (GDMS) is responsible for ensuring that all clinical data management products and services are effectively delivered… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... develop and apply safety evaluation methods (including visual analytics), processes, standards and toolsCollaborate with the Late Development Statistics (LDS)… more
- Merck & Co. (North Wales, PA)
- …& Development (R&D) projects (data, analyses, tables, graphics, listings). Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation ... benefit of patients and global human healthPrimary Responsibilities:Develop and validate global programming standards and tools for the production of Study… more
- Merck & Co. (North Wales, PA)
- …Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good ... health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one… more
- Merck & Co. (Lower Gwynedd, PA)
- …biotherapeutics to support the immunogenicity requirements of regulated drug development studies. Collaboration, innovation, teamwork, and accountability are highly ... our team. The successful candidate will play a key role in method development , validation, and analysis of neutralizing antibody methods for the company's pipeline.… more
- Merck & Co. (North Wales, PA)
- …integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Our company's Global Clinical Trial Operations (GCTO) ... Job DescriptionOur Company is a global health care leader with a diversified portfolio... lifecycle (SDLC) Preferred Experience and Skills: Experience in clinical development , clinical operations, or… more
- Merck & Co. (North Wales, PA)
- …GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of ... consent documents using health literate language per company process and standards to ensure compliance with internal policy, regulatory requirements, and health… more
- Merck & Co. (North Wales, PA)
- …analysis and report programming development and validation, utilizing global and therapeutic area (TA) standards and following departmental ... in clinical trials.Support statistical programming activities for Early Oncology clinical development projects.Responsible for the development and… more
- Merck & Co. (North Wales, PA)
- …objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing strategy and promotional ... promotional materials are aligned with US promotional regulations, corporate standards and policies and business objectives.Actively participate in labeling and… more
- Merck (West Point, PA)
- …development and a chance to see if we are the right company for your long-term goals. Global Clinical Data Standards is a part of the Global Data ... Management and Standards division within Global Clinical Trial Operations. Our mission is...that facilitate our company to effectively and efficiently achieve clinical development milestones that enable our ability… more
- Merck (North Wales, PA)
- … Clinical Trials Operations (GCTO) functions, and where appropriate, other areas of Global Clinical Development (GCD) in any of the following areas: + ... more projects. These opportunities can provide you with great development and a chance to see if we are...are the right company for your long-term goals. The Standards & Training Intern may provide support to … more
- Merck (West Point, PA)
- …Are you passionate about serving patients with quality products? Within our Research & Development Division, the Global Clinical Supply (GCS) organization is ... guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS), Global Development ...to applicable company policies and quality management system (QMS) standards . + Support the overall mission of the GCS… more
- Merck (North Wales, PA)
- …to deliver our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The GSA ... the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is...Development of effective communications + Process improvements + Development of tools to enhance conduct of clinical… more
- Merck (North Wales, PA)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... the GPL involves developing and maintaining efficient, effective, and compliant business standards , process maps, and risk management for global processes across… more
- Merck (North Wales, PA)
- …the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations, Process & Systems (OPS) ... in our Research Division can provide you with great development and a chance to see if we are...is an excellent opportunity to be part of a global process and engage colleagues worldwide. Key learning objectives/experiences… more
- Organon & Co. (Plymouth Meeting, PA)
- …Medical Officer, and is accountable for: + The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), ... from other areas. + Leadership of the following teams: Global Clinical Development , Clinical...assure adequate quality and consistency with company and industry standards . + Develop a thoughtful data management strategy to… more
- Merck (North Wales, PA)
- …and location strategies. + Contributes to the strategic vision and optimization of Global Clinical Trial Organization. **Education Requirements:** + BA or BS ... **Job Description** The Associate Vice President, Global Data Management & Standards (GDMS)...Standards (GDMS) is responsible for ensuring that all clinical data management products and services are effectively delivered… more
- Merck (West Point, PA)
- …supported by the data. As part of the Global Data Management and Standards organization, the Clinical Data Management, Early Development (EDEV) intern ... and management of subject data in compliance with regulatory standards . The goal of these practices is to ensure...and also various other disciplines in the practice of Clinical Development while working on one or… more
- CSL Behring (King Of Prussia, PA)
- …with internal and external cross-functional stakeholders to ensure translation of the clinical development strategy and clinical protocol into operational ... working in a Clinical Operations environment is required.** + ** Global Clinical Operations experience is important.** + **Experience should include… more
