- Takeda Pharmaceuticals (Lexington, MA)
- …investigations. + Masterfully lead within a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (eg, Growth & Emerging ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- Takeda Pharmaceuticals (Boston, MA)
- …part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... project -related analytical control topics, development requirements and program milestones...to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …ensure accurate information, timelines and budgets are completed to support project recommendations to Senior Management. + Generates collaboration, cooperation ... is true to the best of my knowledge. **Job Description** **Associate Director , Clinical Research, Value & Evidence Generation, US Medical** **Lexington, MA**… more
- AbbVie (Cambridge, MA)
- …an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the Specialty and ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Specialty and Discovery… more
- Fresenius Medical Center (Waltham, MA)
- …NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical/clinical development, commercial, and other functional areas ... into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory trends, updates, and… more
- AbbVie (Worcester, MA)
- …and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and ... linking this to local / global project implementation. + Leads product quality team to support...programs; including Brand Teams, New Product Introductions, Product Transfers, CMC , Global Strategic Sourcing, Due Diligence, Site Selection, and… more
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