Manager, Document Excellence Regulatory Operations in Basking Ridge, NJ at DSI

Date Posted: 3/24/2020

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:

Position manages the planning, preparation and delivery of electronic documents for regulatory submission of investigational and marketed products worldwide and can manage an internal/external team of within the Regulatory Operations function. This position requires expertise on US and EU standards for regulatory submissions, confirming that DS documents meet those standards, It also requires coordinating the preparation of all regulatory document components to ensure they are available to meet the global submission timelines.
The Manager is expected to oversee the work of internal and external vendors preparing documents for dossiers. This includes allocating work to internal contractors and outside vendors, ensuring that the work allocated to those vendors is delivered in a timely manner and that the work done is compliant with DS and regulatory authority submission standards. This may involve communicating the DS standards to the internal DS personnel and to vendors. It also involves QCing the work of outside vendors, developing metrics that can be used to assess quality, and, if necessary, working with the vendors and internal staff to retrain their staff to meet DS standards.
This position advises on document strategy and conducts checks of accuracy and consistency of documents intended for submissions. This position works with a high level of independence on complex projects, has a significant degree of latitude in assignments. Additionally, this position demonstrates expert document formatting knowledge, advanced planning experience, and expert working understanding of electronic document management practices and suthoring templates. This position can lead and support the development of global document format requirements and has a general working knowledge of the drug development processes, relative functional capabilities, and interdependencies. This position leads document needs and issues as well as interactions with functional managers. Finally, this position can also lead more junior level staff and supports leadership in submission related tactical discussions and process improvements.
The Manager is also expected to familiarize themselves with the preparation and use of Clinical Regulatory documents and to suggest ways in which the preparation, review, and approval of these documents can be expedited, including developing new ways of using the DS document Management System (CoMET) and other software to achieve industry-leading quality standards. The Manager is expected create and populate protocol and CSR binders in the submissions vault, link documents across vaults, extract documents from the eTMF Vault and use them to create CSR appendices. The holder of the position is also expected to liaise with development project teams and with Regulatory Affairs in the US, the EU and Japan to provide expertise and just in time training in the use of the COMET Submissions Archive Vault, and to coordinate activities so that documents can be shared for worldwide submissions and prepared for posting to public disclosure websites.
The Manager is expected to work with the AD 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.

  • Technology: Supports all document publishing programs, document templates and/or project planning applications. Supervises the identification, compilation, and assembly of required documentation for various clinical/regulatory documents. Advanced, tactical 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. Works with IT and system providers to ensure maximize the utility of document management and publishing systems/tools and to troubleshoot problems
  • 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. Coordinates and oversees the document assembly/production process and structural organization of regulatory documents. Identifies, plans, and manages general business process improvement opportunities. Leads/drives in the development of business processes with internal and external partners. Liaise with cross-functional DS groups to develop processes for document preparation and transmission for inclusion into submissions
  • People: Establishes and maintains effective timely communication across Regulatory Operations including Regulatory Affairs and Clinical Development Operations. Manages document tactical activities. Communicates and actively collaborates with managers and leaders concerning the document process; assists in creating, communicating, and implementing organizational goals and objectives. Trains personnel in regulatory document preparation, review, and publishing and planning activities ensuring compliance. In collaboration with leadership may help to conduct departmental meetings.
  • Document Excellence Team Leadership/Group Facilitation: Demonstrates an expert understanding of document preparation process and role of each contributing discipline. Attends and leads (when appropriate) the document preparation team meetings. May oversee & maintain document planning issues log and begins assuming more responsibility with document planning. Takes leadership role in facilitating Specialist initiatives/meetings. Regularly leads functional meetings with internal/external contributors.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • BA/BS in relevant discipline desired (or equivalent years' experience).
  • 6-8 years industry experience (preferably in Clinical Operations, Regulatory Operations/Regulatory Affairs or project management).
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.