Executive Administrator, Regulatory Affairs

Kyowa Kirin•Princeton, NJ

6d•$82,000 - $93,000

About The Position

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. The Executive Administrator, North America Regulatory Affairs performs and oversees all administrative related services for the Head, NA Regional Regulatory Head. This includes managing complex business calendars, coordinating meetings, coordinating travel arrangements, tracking action items and follow-up on vendor payments. Position requires broad knowledge of corporate operations and policy. A high level of administrative support and advanced computer technology experience is required. Ability to multi-task is essential. The Executive Administrator, Regulatory Affairs must maintain confidentiality, operate with discretion with latitude for independent judgment and initiative.

Requirements

High School Diploma or GED required. Business school, associate degree or equivalent is a plus.
Minimum of eight (8) years of administrative experience supporting senior and C-suite executives, preferably within the biotechnology or pharmaceutical industry.
Advanced proficiency with Microsoft Office Suite(Word, Excel PowerPoint, and Outlook).
Strong interpersonal and communication skills (both oral and written)
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.
Excellent problem-solving skills.
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.

Responsibilities

Provide general administrative support and organizational skills to the VP, NA Regional Regulatory Head as well as Regulatory Affairs team members, as needed
Responsible for the planning and coordination of meetings (on-site off-site): schedule meetings, reserve conference rooms, selection of off-site venues and contracting; preparation and distribution of meeting materials, coordinate audio visual equipment, and food needs; prepare and format documents into final form.
Arrange and complete all aspects of travel: coordinate team travel arrangements (domestic and international); prepare travel itineraries; monitor and process travel or other expense reimbursement in a timely manner.
Manage project timelines to ensure on-time performance, anticipate and mitigate issues and challenges.
Support regional input into budget planning and monitoring.
Maintain calendars and monitor crucial due dates and important events as required.
Process incoming and outgoing e-mail.
Draft and/or proof-read documents and presentations as needed utilizing a strong command of proper business writing and grammar.
Prepare presentations as needed.
Send team and department communications on behalf of KKNA Head, NA Regional Regulatory Head.
Attend meetings, prepare and maintain meeting notes.
Manage documents effectively from and to various software programs (e.g., Excel, Powerpoint) demonstrating confidence with various technologies and the ability to learn new technologies as necessary.
Maintain integrity of electronic document structure for the departments.
Manage contract process and payments/invoices from outside vendors.
Handle general telephone/e-mail inquiries to department(s) and field/answer all routine and non-routine questions.
Identify urgent activities and manage or route appropriately
Suggest and drive improvement processes when applicable.
Comply with all policies and procedures.

Benefits

401K with company match
Discretionary Profit Share
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