Manager, R&D Records Management
Daiichi Sankyo, Inc.

Job Info

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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 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 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.

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 15,000 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.

Summary

This role has the flexibility to function on a remote basis for those outside the region OR corporate Basking Ridge NJ site based.

Responsible for ensuring that clinical records are handled and maintained to the required standards by maintaining awareness of current regulatory, legal, and other relevant guidelines. Deliver on the strategy for Records Management, ensuring the operational aspects are handled daily. Oversee storage system for both electronic and existing paper documents that will allow for identification and retrieval of documents in support of the Trial Master File (TMF) as well as DSPD records across the organization. Ensures compliance in how DSPD and TMF stores, retrieves, refiles, destroys records with high standards and minimal supervision. Interact with external vendors related to Records Management on behalf of Daiichi Sankyo. Work with the Corporate functions and Legal Affairs to carry out the aims of the Records Management Program across DSI. Responsible for application of Legal Hold and interacting with validated systems to ensure Legal Hold is applied.

Responsibilities

• Manages and oversees quality within Records Management and associated business process, looking for improvement opportunities and relentlessly seeking to translate improvement opportunities into realities.
• Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and internal client requests for records.
  Lead awareness efforts and promote/educate employees on Records Management, associated business quality and compliance.
  
  Performing yearly testing of both the DSPD and TMF processes to ensure success during both audits and inspections.
  
• Work with external third parties as necessary in the execution of the Records Management strategy and vision.
  Ensuring compliance in how DSPD stores, retrieves, refiles records, including the TMF records practices.
• Maintain Standard Operating Procedures (SOPs) and Work Instructions for job function within Records Management, discovering and documenting process improvements.
  Recommending the decisions for accurate Legal Hold requirements and destruction of global records based on corporate retention guidelines.

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 Bachelor's degree in fields such as Life Sciences, Records Management methodology, or Scientific Library with 5 years of relevant experience required

Experience Qualifications

• • Experience in the pharmaceutical industry
• • Working knowledge of drug laws, regulations and guidelines is essential
• • A thorough knowledge and understanding of GxP/GCP Records Management is required, including retention requirements and systems utilized in records management for the pharmaceutical industry

Travel

Ability to travel up to 5% In-house office position that may require some travel (domestic or global)

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.

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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