- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- Merck (Raleigh, NC)
- …Analytics, Data Governance, Digital Literacy, Digital Transformation, Informatica Metadata Manager , Management Process, Process Flow Documentation, Project ... Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring… more
- ThermoFisher Scientific (Wilmington, NC)
- …consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, ... on - now and in the future. **Role:** CTM, Senior **Location:** US-Remote, East Coast HIGHLY preferred, may look...activity timelines and metrics, providing status updates to the project manager , regularly reviewing projects using tracking… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Non-Interventional Oversight Team… more
- ThermoFisher Scientific (Greenville, NC)
- …gaining cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Oversight Respiratory Trials ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...and/or programs. Maintains strategic relationships and serves as a senior leadership contact for clients. Provides input to business… more