Assoc Regulatory Document Publishing at Daiichi Sankyo, Inc. in Basking Ridge, New Jersey

Posted in Other 8 days ago.





Job Description:

Job Description



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


Position assists in the preparation and delivery of electronic documents for regulatory submission of investigational and marketed products worldwide. This position requires knowledge on US standards for regulatory submissions, confirming that DS documents meet those standards. It also requires supporting the preparation of all regulatory document components to ensure they are available to meet the global submissions timelines. The Associate is expected to assist in the document preparation work of internal and external vendors for dossiers. This may involve communicating the DS standards to the internal DS personnel and to contractors/vendors. It also involves conducting and e-submission readiness QC on the work of internal, external, and outside vendors. This position conducts checks of accuracy and consistency of documents intended for submissions. This position demonstrates proficiency in document formatting knowledge and the understanding of electronic document management practices The Associate is also expected to familiarize themselves with the preparation and use of Clinical Regulatory documents. This position is expected to create and review the cross-links across vaults and extract documents from the eTMF Vault. The Associate is expected to work with the Manager, Regulatory Operations to develop more efficient and speedy work processes across functional areas that also ensure that quality is built into the document preparation process.


Responsibilities




  • Technology: Supports all document publishing programs, document templates and/or project planning applications. Working knowledge of the changing Health Authority guidelines regarding document standards. Provides input on regulatory submission process improvements and the establishment of repeatable processes utilizing key technologies.

  • Process: Manages the evaluation of processes to ensure organizational responsibilities are met with the highest degree of quality and timeliness for regulatory and clinical documents.

  • People: Establishes and maintains effective timely communication across Regulatory Operations including Regulatory Affairs and Clinical Development Operations. Supports document tactical activities. Communicates and actively collaborates with managers concerning the document process.

  • Document Excellence Team Leadership/Group Facilitation: Demonstrates a proficient understanding of document preparation process and role of each contributing discipline. Attends the document preparation team meetings.




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 or equivalent work experience required



Experience Qualifications




  • 4 or More Years industry experience, preferably in Regulatory Operations/Regulatory Affairs preferred



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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