Associate Director, Labeling Operations in Basking Ridge, New Jersey at DSI

Date Posted: 10/14/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position serves as the RA labeling expert to the Global Regulatory Team (GRT) on the development of labeling packaging components. Establishes the labeling working team for packaging components and provides strategic and operational leadership on the development of packaging components. Collaborates with Supply Chain and Technical Operations on the implementation of artwork changes. This position manages multiple assigned projects of increased complexity including post-marketing projects and those involving 3rd party development. This position partners with GRLs and marketing in the development of packaging components for assigned products. This position drives/leads the maintenance of cartons and external packaging in the US for assigned Daiichi Sankyo products. This position ensures that US packaging components comply with all applicable regulations and guidelines to mitigate potential medication errors. This position interacts across the RA function globally and interacts across functional as well as regional areas. This position often works with ambiguity and complex problems, focusing on strategic and operational decisions.

Responsibilities:
  • Preparation of new and updated US packaging components and documentation: Independently manages, and develops regulatory documents (e.g., draft carton and container labels, draft labeling for launch activities and printed USPI, medication guides, patient labeling). Independently leads cross functional teams through all packaging discussions with the FDA while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA packaging and product launch issues.
  • Ensure Compliance with Labeling Regulations and Guidance: Demonstrates expert knowledge of labeling and packaging guidance. Responsible for company compliance of Structured Product Labeling content of labeling and drug listing regulations and guidance. Manages compliance with US labeling and packaging regulations and guidelines, reviewing cartons and container labels for compliance with regulations regarding both content and format. Ensures cartons and container labels of marketed products comply with current guidelines as needed. Supports creation, update and submission of Structured Product Labeling for labeling and drug listing.
  • Establish and Conduct Label Review Committee Meetings: Establishes the labeling working team for packaging components. Prepares documents independently. Leads processes and associated systems to ensure appropriate review and governance of US packaging (carton and containers labels).
  • Establishes Process and System Best Practices: Serves as a role model and leads the use and implementation of labeling best practices. Assists in the development of Standard Operating Procedures (SOPs) and process improvements (e.g., LWT and ELRC review processes for packaging and automated global labeling implementation management and tracking systems, implementation of artwork management systems).
  • Department Coordination: Builds cross-functional and cross-regional relationships.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Qualified candidates must have a Bachelor’s degree from an accredited college or university; advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred
  • 7+ years pharmaceutical industry experience required with 3+ years of direct experience in US labeling or packaging development
  • Experience with labeling implementation and ex-US labeling a plus
Occasional travel up to 5%

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.