- Mentor Technical Group (Holly Springs, NC)
- …and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy ... with MS Office products (Word, Excel, Outlook, PowerPoint). + Knowledge of regulatory requirements for manufacturing of pharmaceutical products. + Strong written… more
- Merck (Raleigh, NC)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... tools and framework for driving Go/No Go decisions on programs and rapid regulatory approvals + Foster collaboration within QP2 to achieve results, remove barriers… more
- Merck (Raleigh, NC)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory … more
- Cytel (Raleigh, NC)
- …and a strong understanding of statistical programming within a biotech or pharmaceutical environment. The ideal candidate will contribute to the maintenance of ... Listings, and Figures (TLFs) using SAS. Familiarity with GxP standards for regulatory submissions is essential. + Develop and maintain open-source software platforms… more
- Merck (Raleigh, NC)
- …on programs. + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody ... drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical… more
- Chiesi (Cary, NC)
- …accountability for achievement of goals and an eye towards innovation. + Ensure compliance with regulatory , legal, and corporate requirements both separately and ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...systems, and other marketing tools. + Thorough understanding of regulatory , legal and compliance requirements. + Experience… more
- Chiesi (Cary, NC)
- …accountability for achievement of goals and an eye towards innovation. + Ensure compliance with regulatory , legal, and corporate requirements both separately and ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...systems, and other marketing tools. + Thorough understanding of regulatory , legal and compliance requirements. + Experience… more
- Chiesi (Cary, NC)
- …rides, in-office meetings, events, and other activities as needed + Ensure compliance with regulatory , legal, and corporate requirements both separately and ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...skills, both verbal and written + Thorough understanding of regulatory , legal and compliance requirements. + Experience… more
- Lilly (Durham, NC)
- …procedures + Provide technical and quality review and approval documents to ensure compliance with Lilly Global Quality Standards as well as global and local quality ... batch + Build a capable organization to support quality oversight, and ensure compliance with area procedures and controls for material and product record review and… more
- J&J Family of Companies (Wilson, NC)
- …Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and ... a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements. + Coordinates and executes training… more
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