Global Regulatory & Pharmacovigilance IT Leader

Kyowa Kirin North America; Princeton (NJ); On-site; USD 175,000 - 190,000; Full time

Benefits offered by this job

401K with company match

Annual Bonus Program

Generous PTO/Holiday Schedule

Healthcare Benefits

Well-Being and Work/Life Programs

Life & Disability Insurance

Long Term Incentive Program

Pet Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America is seeking an Associate Director to lead Regulatory Affairs and Pharmacovigilance IT initiatives. The role partners with IT leadership and global stakeholders to deliver advanced systems and platforms, ensuring operational excellence and value realization across RA and PV domains.

The position requires a strong technical/CS background, 10+ years in pharma R&D technology support, and fluency in GxP and SDLC, with responsibility for budgets, vendors, and multi-region

Qualifications

• Bachelor's degree in science, Engineering, or Business required.
• Advanced Degree in Technical, Engineering field preferred.
• A strong computer science background with industry experience.
• Knowledge of RA and PV business processes.
• Demonstrated operational support background.
• GxP and SDLC fluency.
• Strong cross-functional partnering and communication skills.

Responsibilities

• Partner with business teams to support operational, tactical, and strategic outcomes.
• Work with stakeholders to define, design, propose, and oversee solutions.
• Support and ensure completion of analytical, building, testing and deployment tasks of projects within Clinical Business organizations.
• Partner with global IT colleagues on RA and PV initiatives.
• Ensure operational excellence in day-to-day operations of clinical suites and platforms.
• Work on global teams as RA and PV technology SME.
• Capture, manage, and prioritize business demand and manage investment portfolios.
• Manage area and project budgets, vendors, contracts.

Skills

Computer science background

RA and PV knowledge

Operational support

GxP fluency

SDLC fluency

Cross-functional partnering

Communication skills

Education

Bachelor's degree in science/engineering/business

Advanced degree preferred

Tools

Veeva RIMS

Oracle Argus

Job description

Kyowa Kirin North America is seeking an Associate Director to lead Regulatory Affairs and Pharmacovigilance IT initiatives. The role partners with IT leadership and global stakeholders to deliver advanced systems and platforms, ensuring operational excellence and value realization across RA and PV domains.

The position requires a strong technical/CS background, 10+ years in pharma R&D technology support, and fluency in GxP and SDLC, with responsibility for budgets, vendors, and multi-region