- Takeda Pharmaceuticals (Lexington, MA)
- …Development on cross-functional teams. + Author and review CMC documents for regulatory submissions and address global health authority questions. **What You ... risk analyses to inform program strategies. + Drive quality control and regulatory strategies for late-stage development, including BLA/MAA submissions and… more
- Pfizer (Cambridge, MA)
- …other statisticians, study managers, alliance partner colleagues - for assigned studies and regulatory submissions . + Provide input to the Statistics Group Lead ... result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and… more
- AbbVie (Cambridge, MA)
- …peptide drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions , and ... to execute and deliver material and information for clinical trials and regulatory submissions . + The candidate will identify and nurture ideas for continuous… more
- Sanofi Group (Cambridge, MA)
- …be leading and overseeing all statistical work for clinical development and regulatory submissions , leading a team focused on clinical development strategies, ... and competencies in clinical development or post-marketing activities such as submissions , interactions with regulatory agencies (including NDA/BLA and EMA… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … agencies and be responsible for clinical pharmacology summary documents for regulatory submissions . + Oversees and/or independently performs PK, PD, and ... applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA, EMA and others). + Advanced… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … agencies and be responsible for clinical pharmacology summary documents for regulatory submissions . + Oversees and/or independently performs PK, PD, and ... pharmacology studies. + Extensive experience in late-state drug development, regulatory submissions and life-cycle management. + Hands-on expertise/knowledge… more
- Cytel (Cambridge, MA)
- …the pre-specified timelines + Support the preparation of clinical study reports, regulatory submissions , publications, annual DSUR, and exploratory analyses + ... medical terminology, clinical trial methodologies, and FDA/ICH regulation + Experience supporting regulatory submissions , interacting with the FDA and/or global … more
- Merck (Cambridge, MA)
- …(GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions . The candidate will play a key role in ... influence scientists to adapt to positive change. * Experience with regulatory submissions and understanding of the review process. * Familiarity with… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …startup activities, providing training to participating site research staff, regulatory submissions , safety event tracking and reporting, deviation/violation ... start-up activities, coordinating and managing site activation, research staff training, regulatory submissions , event tracking and reporting, deviation and… more
- Point32Health (MA)
- …health care providers and institutions. Responsibilities include supporting provider negotiations, regulatory submissions , RFP/UDS submissions (as well as ... Point32Health network. + Support RFP work including continuous improvements to the UDS submissions and create tools required to support quick turn arounds of RFPs. +… more
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