Global ICT Business Partner (Regulatory Affairs & Pharmacovigilance)

Overview

Global ICT Director Regulatory Affairs (RA) and Pharmacovigilance (PV)

at Kyowa Kirin International plc

Hybrid with our European offices: Marlow - UK, Paris – France, Madrid – Spain, Dusseldorf - Germany

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose:

This self-starting leader will partner with IT leadership, business partners and stakeholders globally, to deliver increasing capabilities to Regulatory and PV. You will oversee business relationship management, operational excellence, vendor management and project execution and work with teams to innovate and manage business demand, prioritise initiatives, and ensure value realisation.

Responsibilities

Key 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 organisations
• 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
• Manage area and project budgets, vendors, contracts

Qualifications

Position Requirements:

• Bachelor's degree in science, Engineering, or Business field required
• A strong computer science background, demonstrated through industry experience
• Significant 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
• Experience with Veeva RIMS, Oracle Argus (desirable)
• Detail oriented
• Ability to deal with ambiguity in a dynamic, fast-paced, high growth environment

Kyowa Kirin International is an equal opportunities employer.