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.

Summary:

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.

Essential Functions:

• 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

Requirements :

Education
• Bachelor's degree in science, Engineering, or Business field required.
• Advanced Degree in Technical, Engineering field preferred

Experience
• 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

Technical Skills
• Proficient in MS Office Suite.
• Experience with Veeva RIMS, 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 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.

The anticipated salary for this position will be $175,000 to $190,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 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

The compensation and benefits information set forth in this posting 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.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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