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Director Labeling in Bernards, NJ at DSI

Date Posted: 4/10/2019

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.


Job Summary:

This position serves as the RA Labeling expert driving the development, implementation and compliance monitoring of global labeling processes and IT systems in response to changing regulatory requirements, mergers and acquisitions, organizational restructuring and optimization. This position will be responsible to develop processes and manage quality reviews/proofreading for the CCDS, US and EU labeling, including US packaging components and SPL. This position will manage creation of SPL, integrating the process with vendors and cross-functional subject matter experts. 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. This position works on complex issues and acts as a decision maker with management alignment.

Responsibilities:

  • Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues.

  • Ensure Compliance with Core Data Sheets/Label Changes: Provides labeling development strategic plan and has broad oversight for Core Data Sheets/label changes. Manages US and local country labeling deviations from CCDS; reviews and approves CCDS/labeling agreements for licensing partners.
  • Conduct Label Review Committee Meetings: Prepares documents independently. Leads processes and associated systems to ensure appropriate review and governance of US, EU and global Company Core Data Sheet documents.
  • Ensure Compliance with Labeling Regulations and Guidances: Demonstrates expert knowledge of labeling guidances. Manages compliance with labeling regulations and guidelines, reviewing package inserts, cartons and labels for compliance with regulations with regard to both content and format. Ensures inserts, cartons and labels of marketed products comply with current guidelines as needed.
  • 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., LRC review process and automated global labeling implementation management and tracking systems) and develops optimal CCDS/labeling agreement templates for licensing partners.
  • Department Coordination: Builds cross-functional and cross-regional relationships.
  • People Management: Mentors RA staff and/or matrix team members.

Qualifications:

Education:

  • Bachelor’s Degree, preferably in a scientific discipline; prefer an advanced degree (e.g., Masters, Pharm.D., Ph.D.)

Experience:

  • 10+ years pharmaceutical industry experience required with 5+ years of direct regulatory affairs experience, including US labeling experience
  • Experience with ex-US labeling a plus (outside the US)