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Procedural Document Writer
Ref No.: 18-19586
Location: Lawrenceville, New Jersey
Procedural Document Writer
Lawrenceville, NJ
6+ Month Contract

Expected Areas of Competence
  • Ability to develop a range of written materials such as detailed instructions for high level principles-based documents.
  • Demonstrated ability to write complex processes in a logical order using simplified language, creation of visual process flow diagrams, and information mapping techniques
  • Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape
  • Ability to effectively manage projects, escalate issues as necessary and meet key milestones
  • Ability to lead and facilitate writing team meetings, that contribute to attaining team goals and resolving complex issues
  • Ability to evaluate utility of documents and assemble content to ensure clarity for users (including those who are not native English speakers)
  • Collaboratively work with Regulatory and Clinical colleagues to ensure any process changes resulting from the issuance of new or revised GCP/ICH Guidelines, regulations, and other guidelines applicable to clinical research are documented appropriately, in an appropriate format
  • Work with autonomy and is able to able to negotiate and influence others without direct authority

  • Bachelor's degree with a minimum of 5-10 years experience in global drug development
  • Demonstrated knowledge of Good Clinical Practice (GCP) ICH
    Guidelines and applicable FDA regulations
  • Project Management:
    • Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
    • Demonstrated ability to maintain a high level of productivity, accountability and energy
    • Demonstrated success in managing project team effectiveness, through facilitation and presentation skills to a globally diverse audience
  • Document Development and Review:
    • High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper
    • Provides close attention to detail and excellent follow up
    • Ability to take very detailed information and distill it down to focus on key messages
  • Flexible thinker with a growth mindset
    • Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
    • Affinity towards fully utilizing technology