- AbbVie (North Chicago, IL)
- …Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that the CMC ... development strategy and provide drug development experience and advice to the CMC team. Influence development of new regulatory guidance, assure timely impact… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Program Manager/ Associate Director , CMC Portfolio Management will provide ... cross-functional teams to achieve key asset milestones. The Senior Program Manager/ Associate Director will provide timeline/scenario planning and program… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... in nonclinical areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she is also responsible… more
- AbbVie (North Chicago, IL)
- …interfaces across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), Quality Assurance (QA), CMC Coordination, ... Product Development Science and Technology (PDS&T), among others. + Develops and aligns in close cooperation with stakeholders globally, phase-appropriate lean development processes, workflows, and GMP approaches for ARD cross-functionally. + Authors, reviews,… more
- AbbVie (North Chicago, IL)
- …groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams. + Responsible for the appropriateness, quality and accuracy ... of pharmacometrics deliverables. Advice on complex methodologies such as advanced analytics, machine learning and mechanistic modeling + Contribute to development of departmental goals. Influences strategic PK/PD decisions for the department. + Champion… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present at ... national and international conferences and interact with KOLs/external stakeholders. + Conducts due diligence assessments, summarizes results and represents Clinical Pharmacology on business development teams. + Represents Clinical Pharmacology at regulatory… more