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Document Management Specialist

  • Job reference: 930505
  • Location: Uxbridge, London
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 17/03/2020

Orion Group Life Sciences are looking for a Document Management Specialist for our multinational pharmaceutical client based in the Middlesex area on an initial 12-month contract with the potential to extend.


Job Purpose

To support the management of Research and Development (R&D) controlled processes and the creation and/or revision of associated documentation.
This is an opportunity to work for a pioneer in biologic therapies, who discovers, develops, and delivers innovative human therapeutics. As a member of the R&D Quality Compliance and Audit (QCA) group, you will be responsible for supporting the development of controlled documentation for R&D processes.

Main Responsibilities of the role

  • Management of R&D process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality
  • Development and facilitation of the creation and/or revision of materials such as SOPs, manuals, and related business process documentation in conjunction with Subject Matter Experts. Note: these activities will usually take place virtually and across different time zones
  • Liaison with other members of the QCA group (e.g. Business Process Modellers) and also the business (e.g. Business Process Owner, Document Owner, Authors, Subject Matter Experts)
  • Management of documents via the established R&D Document Review process using the electronic document repository
  • Development of regulated or process documents with the ability to deliver high quality documentation including technical writing
  • Track and provide regular updates to process project inventory tool and to key Points of Contact
  • Role will receive appropriate training and orientation to support delivery of the responsibilities including:
    QCA Process Documentation Management Role Based Curriculum (including Learning Management System courses and SOPs)
    * Introduction to QCA group and related activities
    * Controlled document template and style guide

Desired Experience and Background of the successful candidate

  • Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing
  • Sound project management and organizational skills
  • Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation
  • Experience in leading virtual teams within different regions and cultures
  • Proficient in discerning, high quality verbal and written communication
  • Experience of electronic clinical trial/SOP/document systems
  • Good working knowledge of Microsoft Word
  • 3+ years' experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance

For more information on this role, call Kate O' Sullivan on +353 860327942or email Kate.OSullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930505


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.