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

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

About the role

Kyowa Kirin Information & Communication Technology is seeking a dynamic and independent Regulatory and PV IT technology professional to join 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 Pharmacovigilance (PV). The role involves overseeing business relationship management, operational excellence, vendor management, and project execution, while innovating and managing business demand, prioritizing initiatives, and ensuring value realization.

Responsibilities

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

Requirements

• Bachelor’s degree in science, Engineering, or Business field required. Advanced Degree in Technical or Engineering field preferred.
• At least 10 years’ experience in pharmaceutical R&D technology support.
• Strong computer science background, demonstrated through industry experience.
• Knowledge of business processes in Regulatory Affairs (RA) and Pharmacovigilance (PV).
• Demonstrated operational support background.
• Fluency in GxP and Software Development Life Cycle (SDLC).
• Track record of partnering cross-functionally with a wide range of stakeholders and teams.
• Passion for communication with partners and delivering technology outcomes that drive business goals.

Skills

• Technical Skills: Proficient in MS Office Suite. Experience with Veeva RIMS and Oracle Argus.
• Non-Technical Skills:
  • Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly.
  • Strong interpersonal and communication skills.
  • Strong work ethic, detail-oriented, and excellent follow-through.
  • Ability to flex and deal with ambiguity in a dynamic, fast-paced, high-growth environment.
  • Passion for personal learning and development to grow with the company.
  • Cultural sensitivity and ability to develop consensus within a multinational organization.

Pay

The anticipated salary for this position is $175,000 to $190,000. The actual salary offered may vary based on relevant experience, skill set, qualifications, education, location, and other business and organizational needs.

Benefits

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule, including 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

The compensation and benefits information applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.