Senior Manager Global Category-Digital Health and Regulated Tech
HyderabadFull-timeSenior levelPosted over a month ago
Senior software engineering role at Amgen in Hyderabad.
About the role
Lead category management for Digital Health and regulated technology software supporting clinical trials, patient engagement, and regulated applications. Partner with R&D, Clinical, Regulatory, and Compliance teams to ensure alignment with FDA, EMA, HIPAA, and GDPR standards. Negotiate contracts with vendors of e-clinical, ePRO, EDC, and patient-facing apps, balancing innovation with compliance.
What you'll do
- Lead category management for Digital Health and regulated technology software supporting clinical trials, patient engagement, and regulated applications
- Partner with R&D, Clinical, Regulatory, and Compliance teams to ensure alignment with FDA, EMA, HIPAA, and GDPR standards
- Negotiate contracts with vendors of e-clinical, ePRO, EDC, and patient-facing apps, balancing innovation with compliance
- Build governance frameworks ensuring cybersecurity, data privacy, and quality system compliance for regulated digital solutions
What you need
- Data privacy
- Clinical research