- ThermoFisher Scientific (Indianapolis, IN)
- …Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Clinical Affairs , Senior - Study Operations** In this role, ... planning and study execution Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective… more
- Lilly (Indianapolis, IN)
- …clinical experience, the Cardiovascular/Cardiometabolic Business Unit - Global Medical Affairs Clinical Research Physician (CRP) Senior /Executive Director ... responsibility of the Cardiometabolic Health Business Unit - Medical Affairs Senior /Executive Director is to provide expert...as requested Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules ... expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including… more
- Sumitomo Pharma (Indianapolis, IN)
- …relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Sumitomo Pharma (Indianapolis, IN)
- …relationship with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Parexel (Indianapolis, IN)
- …will include ongoing partnership with Client QA and acting as the link between Clinical Development, study teams, global business functions and regional study ... **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a...of the quality management system are in place for studies conducted in partnership with non-commercial organizations (eg NGO,… more
- Lilly (Indianapolis, IN)
- …design, patient engagement priorities making data informed decisions + Partner with Clinical Development, Medical Affairs and clinical capabilities partners ... determined to make life better for people around the world. Purpose: The Senior Director, Investigator Engagement - Neuroscience Therapeutic Area Lead is a strategic… more
- Lilly (Indianapolis, IN)
- …the global team (including alliances). Be aware of and ensure that all medical affairs activities are in compliance with Good Clinical Practices (GCPs), company ... the compound team that reports through MDU or Medical Affairs . The Director GI Portfolio and Pipeline will facilitate...improved patient outcomes; this work may be RCTs, observational studies , pre- clinical works, or post-hoc analyses of… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …that milestones are met. + Support strategy leads by managing the study operational execution of studies including protocol development, vendor selection, ... and other integrated data generation initiatives. This position reports to the Senior Director, Global Integrated Evidence & Innovation Operations and can be based… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- … Clinical Development, Value and Real-World Evidence, Regulatory, Medical Affairs , Data and Analytics, Digital Health and Commercial functions. The successful ... evidence planning and generation. This position reports to the Senior Director, Global Integrated Evidence Strategy and can be...or marketplace dynamics. + Provide expert scientific feedback on study concepts and study protocols in governance… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including sample collection, storage conditions, and ... mitigation strategies. + Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth… more
- Lilly (Indianapolis, IN)
- …by collaborating, leading, and influencing medical leaders across Global Medical Affairs , Value Evidence & Outcomes (VEO), Global Clinical Development, ... Strategy/Plan to leadership and to others as applicable. + Carefully studies and develops/maintains expertise on the publication environment (and other communication… more