Project Lead, Label Development Mgmt

4 weeks ago

Trenton, United States Daiichi Sankyo 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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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 This position is responsible for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical Trial Material (CTM) and will also serve as the Subject Matter Expert (SME) for the SaaS and cloud-based label phrase library, working collaboratively with the CSO Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites for GMP processing operations. This position will work with a label translation company to supplement the phrase library as required and will work with the CSO Continuous Improvement function to establish industry-leading label development process that incorporates global regulatory requirements while incorporating flexibility and simplicity in the design of clinical labels.

Role Responsibilities - Manage end to end label development process for assigned projects / clinical studies in close collaboration with CSO PM’s. Works closely with the label translation vendor to supplement the phrase library with new phrases as needed. Develops label templates within label phrase library to accelerate label development timelines and improve Quality. Evaluates and makes recommendations towards preferred provider for label printing duties across the portfolio. Monitors label printing vendor key performance metrics and collaborates with internal stakeholders and vendors to address project challenges as needed. - Serve as SME for Prisym 360 label phrase library maintenance and scope expansion, as applicable. - Manage label translation vendor(s) to supplement regulatory compliant label text not present within the phrase library. - Collaborate with CSO Continuous Improvement to propose industry leading process improvements designed to reduce cycle times, improve Quality and decrease costs. 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 pharmacy, biochemistry, (bio) chemical engineering, chemistry, or other discipline within pharmaceutical/biotechnology sciences or related field required - Master's Degree preferred Experience Qualifications

- 4 + years of related experience related experience, including IT/system management in Pharmaceutical Development / Clinical research, and Project Management required - 1+ years of experience in the development of parenterally-delivered oncology drugs Travel Ability to travel up to 10% Overnight/single-day travel will be required. Communications (electronic and teleconference/videoconferencing) across all global time zones, global and domestic travel required. 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.

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