Location: Basking Ridge,NJ, USA
Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.
Summary
Deliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. Develop a strong, positive strategic business partnership with various business functions of Daiichi Sankyo. As a trusted partner, provide oversight of business demand to balance IT portfolio and to ensure that partners receive the highest possible business value, while subscribing to the enterprise IT strategy.Responsibilities- Collaborate cross-functionally with stakeholders to align IT projects with business goals, gather input, prioritize initiatives, and develop functional IT roadmaps in alignment with Daiichi Sankyo's mid-term goals. Aid in the delivery of a strategic short- and long-term IT transformation plan to business, ensuring continuous improvement and optimal solutions that support business processes as well as unmet business needs.- Work with User Support Leads and IT System Owners to define user information needs. Collect ideas for upcoming projects and help develop business cases to secure the necessary funding and resources for their successful implementation.- Stay abreast of emerging technologies and trends in the areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system owners so they can deliver applications solutions to meet business needs.- Assemble and manage applications solutions implementation teams (including external vendors) in the design, development, implementation, validation, roll-out, training and support of global and regional DS applications to meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the Services organization to ensure smooth transition from system implementation to maintenance. Identify, assess, and mitigate technical, regulatory, and operational risks while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that are required to update both management and the business on the progress and status of informatics projects. Contribute to the IT portfolio management process and participate in IT and governance forums.- Provide identification and evaluation of new information systems and technologies as they relate to the DS business; provide IT Application solutions/innovations.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)- Bachelor's Degree in Computer Science, Life science, Engineering, Business Administration and / or a related discipline required- Master's Degree in Life Science or Engineering or Information systems preferred
Experience Qualifications- 10 or More Years At least 10 years experience in applications development and operation in the pharmaceutical industry within the appropriate regulatory guidelines required- 4 or More Years [Required for GxP/Regulated: Experience in working within the framework of 21 CFR Part 11, SDLC, GAMP, ICH.] required- [Required for Non-GxP/Non-Regulated: Experience in working within the framework of SDLC, SIAM, ITIL] PMP Certification preferred
Licenses and Certifications- Certification in Business Transformation methodologies preferred- Certification in Organizational Change Management methodology preferred- PMP Certification preferred
Travel
Ability to travel up to 10% Travel to DSPD, DSD, DSE, DST locations which will include overnight travel. Ability to travel to US, EU and Japan.
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.