Associate Director, Regulatory Affairs (RA) and Pharmacovigilance (PV) ICT

Kyowa Kirin North America•Princeton, NJ

1d•$175,000 - $190,000

About The Position

Kyowa Kirin Information & Communication Technology is seeking to add a dynamic and independent Regulatory and PV IT technology professional to its R&D IT Healthcare team. This self-starting leader will partner with IT leadership, business partners and stakeholders globally, to deliver increasing capabilities to Regulatory and PV. This person will oversee business relationship management, operational excellence, vendor management and project execution. They will work with teams to innovate and manage business demand, prioritize initiatives, and ensure value realization.

Requirements

Bachelor's degree in science, Engineering, or Business field required.
A strong computer science background, demonstrated through industry experience
At least 10 years’ experience in pharmaceutical R&D technology support
Knowledge of business processes in RA and PV
Demonstrated operational support background
GxP and SDLC fluency
A track record of partnering cross-functionally with a wide range of stakeholders and cross-functional teams
A passion for communication with partners and delivering technology outcomes that drive business goals
Proficient in MS Office Suite.
Experience with Veeva RIMS, Oracle Argus.
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly.
Strong interpersonal and communication skills.
Strong work ethic is required. Detail oriented and excellent follow through.
Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company.
Cultural sensitivity and ability to develop consensus within a multinational organization.

Nice To Haves

Advanced Degree in Technical, Engineering field preferred

Responsibilities

Partner with business teams to support operational, tactical, and strategic outcomes
Work with business stakeholders in defining, designing, proposing, and implementation oversight of solutions
Support and ensure the successful completion of analytical, building, testing and deployment tasks of the projects and initiatives within the Clinical Business organizations
Partner with global IT colleagues on RA and PV initiatives
Ensure operational excellence in day-to-day operations of clinical and associated 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

Benefits

401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Life & Disability Insurance
Concierge Services
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards