Manager, Clinical Publishing in Bernards, NJ at DSI

Date Posted: 5/6/2018

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

The Manager, Clinical Publishing Regulatory Operation will primarily be responsible for managing the planning, preparation, and delivery of electronic clinical documents for inclusion in regulatory submissions (IND, NDA, Agency Responses, others) required to support the development and registration of new products for worldwide customers.

The Manager, Clinical Publishing will lead a globally focused team of electronic publishers and document specialists in preparing and archiving submission-critical clinical regulatory documents for use in electronic submissions to regulatory agencies worldwide. This will include maintaining expertise on US and EU standards for regulatory electronic submissions, ensuring that DS clinical documents meet those e-submission standards, and coordinating the preparation of all clinical components of regulatory dossiers to ensure that components are available for timely use in global submissions.

The holder of this position will also be expected to evaluate and implement new technologies, to develop processes and procedures that will enable Daiichi Sankyo to produce documents more efficiently and to achieve industry-leading quality standards. The holder of the position is also expected to liaise with clinical project teams, and with Regulatory Affairs in the US, the EU, and Japan, with CSPV and TMCP in the US and Japan to provide expertise and training, and to coordinate activities so that documents can be shared for worldwide submissions.

Responsibilities

1. Manages the document-preparation process from initiation through approval for major Regulatory submissions (IND, NDA, Agency Responses, others).
  • Leads publishing team meetings
  • Participates in dossier planning meetings and provides input on the creation and timing of submission documents.
  • Creates and maintains document-publishing timelines.
  • Liaises with Regulatory Operations to ensure timely publishing of dossier components for submissions
  • Provides guidance/training to the Submission Teams on internal document submission standards and processes
2. Keeps current with latest Regulatory Authority guidelines and provides advice to members of Medical Writing, Clinical Development, Clinical Operations, CSPV, and TMCP.
3. Manages outside consultants (vendors, CRO’s) as needed. Evaluates outside consultants for compliance with internal DS standards and external regulatory standards.
4. Trains a publishing staff to prepare documents to DS standards and oversees the performance of the publishers to ensure quality and timeliness standards.
5. Liaise with other DS group to develop processes for document preparation and transmission for inclusion in submissions.
6. Work with IT and system providers to ensure the appropriate document management and document review systems are selected and implemented.
7. Work with IT and system providers and owners to troubleshoot problems.

Qualifications

Education
  • Bachelors degree, or an equivalent combination of education and experience
Experience
  • >5 years experience in working with electronic publishing software, electronic document management systems, and MSWord, preferably in a pharmaceutical regulatory environment.
Competencies
  • A thorough knowledge and understanding of Health Authority regulations, guidance documents and the drug development process is required. The ability to plan and manage multiple, complex dossier plans simultaneously is required. Self-sufficient, self-motivated, excellent leadership skills, able to prioritize and delegate, detail-oriented, good interpersonal skills, ability to effectively communicate in writing and orally with peers and upper management.
  • Advanced computer skills (MS Word, Excel, Project and Adobe Acrobat) are vital. Understanding of templates and authoring tools is a plus.
  • Extensive electronic publishing experience is required.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.