Associate Director, Regulatory Information Management

Location
Basking Ridge, NJ, United States
Posted
Feb 25, 2021
Ref
10723BR
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Associate Director, Regulatory Information Management (RIM), supports the Research & Development organization by leading or participating in projects and initiatives that optimize the use of information technology to achieve Regulatory Management Operations, Regulatory Affairs, R&D, and Enterprise strategic & tactical business objectives. The Associate Director will play a lead role in the business use of Regulatory Information Systems that support day-to-day regulatory and global development operations in the United States, Europe, and worldwide.

This role regularly collaborates with regulatory & business leadership, business process owners, business analysts, and information technology specialists to design or improve business processes, introduce or maintain data and process standards, implement new systems or enhance existing systems, and effectively administer & operate current systems. This role often involves the oversight of internal or contracted staff, leadership or direct management of projects and initiatives, participation in or leadership of various working groups or teams, as well as the completion of direct hands-on tasks and assignments. The Associate Director works under the direction of the Director, Regulatory Information Management in supporting the RIM Program.

Responsibilities:

EDMS Submissions Management & Archiving: Utilizes expert working knowledge of EDMS practices & technologies to provide leadership, facilitate projects & initiatives, drive necessary system & process enhancements, and ensure operational excellence in enabling the optimized use of the global EDMS system in support of submissions management & archiving processes, worldwide

RIM Projects & Initiatives: Provide leadership and expertise in the execution of business process-related tasks and deliverables required to implement or improve regulatory and R&D business processes and information technology capabilities

Working Groups and Teams: Lead and/or contribute to Regulatory Affairs, Regulatory Management Operations, or RIM working groups and teams formed to address areas of improvement within the Regulatory and R&D scope of operations

System Administration & Operational Support: Define, monitor, and improve the administrative and operational business support of RIM Systems - including, but not limited, to procedural documents, user testing & training, and issue resolution.

Process & Data Standards: Identify, contribute, and lead efforts to standardize RIM data and processes to enable information management efficiencies regionally and globally

Special Projects or Assignments: Lead or contribute to ad hoc RIM projects or assignments, as necessary

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's Degree or Master's Degree in Management Information Systems, Life Sciences or related field required

7 or more years' Experience in the pharmaceutical industry with 7-10 years of direct regulatory operations and/or information management experience

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Job Title
Associate Director, Regulatory Information Management

City
Basking Ridge

Functional Area
Regulatory Management Operations

State
New Jersey