Manager, PMRP and PGC, Legal Operations in Basking Ridge, NJ at DSI

Date Posted: 6/29/2020

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 is responsible for the day to day management and oversite of two company review processes: (1) the Programs and Grants Committee (PGC) process for Daiichi Sankyo Pharma Development (DSPD), Daiichi Sankyo U.S. Business (DSUSB) and the U.S. Corporate Division (USCD); and (2) the Product Material Review Process (PMRP). Working with and reporting to the Associate Director of Legal Operations, this position identifies and implements improvements to these processes; is responsible for measuring the progress against objectives (e.g., metric reporting); supervises and delegates work to staff who are conducting these processes; manages policies and procedures for these processes; provides training; works directly with attorneys for PGC and PMRP items for review; and manages enhancements of the systems for these processes as well as reporting needs.

Responsibilities:

Oversees the PGC process, including supervision of staff who intake and organize requests into systems from DSPD, DSUSB and USCD areas of the Company, and who (a) conduct independent initial review of requests for compliance with policy and procedural requisites; (b) independently determine substantive approvals of items under “blanket approval” protocols authorized by the PGC Steering Committee; and (c) engage in related direct contact with field representatives and management with follow-up requests and questions. Interact with lawyers on important PGC items going through the process and oversee the PGC workflow, preparation of meeting agendas for both PGC and the PGC Steering Committee. Facilitate escalation process from PGC to PGC Steering Committee and/or upper management as needed.

Oversees the PRMP for both regional and global product material, including supervision of staff who intake and organize requests into systems, and who: (a) conduct independent initial review of requests for compliance with policy and procedural requisites; (b) engage in related direct contact with “initiators” from Marketing, Sales, Sales Training, Public Affairs, Global Medical Affairs, Global Marketing and other management with follow-up requests and questions; (c) perform QC review on final materials vs. PMRT approval instructions; (d) prepare and timely file all promotional materials with FDA on form 2253 as required by law and regulation, including self-auditing and QC checks against PMRT approvals, materials inventories, and other appropriate steps to ensure that all required items are filed (1) with appropriate documentation in the correct manner; (2) in a timely fashion; and (3) with appropriate internal recordkeeping. Interact with lawyers and other stakeholders, both locally and globally on important PMRT items going through the process and oversee the PMRT workflow, preparation of meeting agendas for weekly PRMP Meetings. Facilitate escalation process from PMRT to PMRT Steering Committee and/or upper management as needed.

Manage and oversee reporting needs for PGC and PMRP, including creating and coordinating monthly status reports for management and metric tracking of established timelines. Will also be responsible for overseeing and executing the running of ad-hoc reports within the PGC and PMRP systems for management and various business departments. Responsible for assisting in leading and implementing changes and enhancements to all systems associated with PGC and PRMP, building business case requirements and interfacing directly with other departments (i.e., Finance, IS, Marketing, external consultants) on implementation of enhancements and system requirements, as well as assist in the decision making related to systems impact on related policies and procedures.

Periodically check status within Product Material Veeva Platform to review and confirm status within system. Identify Product Material remaining in draft for over three months to confirm is still viable

Provides continuous training on process and technology for PGC and PMRP to ensure compliance by all users of the systems. Assists in preparing training materials and conducting of training to both large and small groups of employees (administrative staff), and also provides one on one training.

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

Education/Experience:
  • 4 Year College Degree Required
  • 3 Years managing process and/or people preferred
  • 3-5 Years in Marketing/Marketing Operations, Editorial, Agency or relevant experience (Pharma specific)
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.