Manager, Document Control CSPV in Bernards, NJ at DSI

Date Posted: 11/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/15/2018
  • Job ID:
    9384BR

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.

The position is responsible for the following:
  • Documentation Program: Takes a lead role in the design and development of a Document Control program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Program will give the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.). Coordinates with the CSPV Training Manager, the correct profiles for each Function within CSPV and ensures the appropriate documentation is contained within the training profile.
  • Documentation Development and Delivery: Takes a lead role in the design and development of SOPs, SOIs and Guidance Documents and associated forms and templates related to CSPV. Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents. Strives to ensure the process is also optimized for efficiency and clarity. Ensures associate understanding of the process documented and resolves and responds to documentation issues and questions. Working closely with the PMO Business Excellence team, support process redesign initiatives by updating relevant documentation for changes to processes.
  • Documentation Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents. Responsible for inspection readiness activities related to documentation. Supports all internal and external partner audits for documentation requirements.

Qualifications

Education and Experience
  • Bachelors of Science degree required
  • Minimum of 5 years drug safety experience
  • MS, RN, or PharmD preferred, or 7 years total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development
  • 3-4 years of direct experience in Document Develop and Document Management focusing on SOPs and SOIs in the PV area.
Competencies
  • Ensures high quality work is completed throughout the function and that internal and external expectations and timelines are met.
  • Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
  • Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
  • Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
  • Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
  • Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.

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.