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Process Writer, Process and Procedures

Basking Ridge, NJ 07920

Posted: 04/19/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 601235 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 60-90/hr **salary will be commensurate with experience 

The Global Development Process & Procedures (P&P) Process Writer is responsible for project facilitation and creation of  Global Development process documents in collaboration with Process Owners and Subject Matter Experts.

  • Manages and leads projects for the development of procedural documents for global development by:
    • Assessing how the creation or update of procedural documents impacts other procedural documents through the management of document Impact Assessments.
    • Identifying the stakeholders/SMEs and ensures they are engaged in the content development/revision activities, including review and approval cycles.
    • Lead the Technical Writing of Global Development procedural documents in collaboration with functional process owner and cross-functional SME(s) by translating complex cross-functional concepts to process maps and documentation ensuring any open process deviations, inspection commitments, corrective/ preventative actions and critical gaps are addressed.
    • Facilitate process mapping activities capturing process details (scope, boundaries, inputs, outputs, process steps and sequence) while allowing for the visualization of data flows, identification of bottlenecks and waste, and minimizing redundancies. Identify and evaluate issues and/or gaps in processes and propose effective resolutions.
    • Facilitate the adjudication of comments from documentation reviews.
    • Collaborate with Quality Managers during content development to ensure alignment with Content Standards and Lean Writing Principles
    • Manage document review and approval workflows.
    • Maintain project schedule, identifying and mitigating risks or issues, escalating to leadership as applicable.
  • Contribute to P&P improvements as applicable.
  • Collaborates with Global Development Training, Change Management, and GD Quality when applicable, to support process implementation
  • Other duties, as assigned.

May require up to 25% travel

  • Minimum 7 years’ experience in a global regulated organization
  • Minimum 5 years’ working in a technical writing position
  • Ability to understand and discuss complex information with people of diverse occupational backgrounds
  • Ability to understand and translate complex processes into lean processes
  • Experience in Microsoft Visio or other process mapping tools
  • Excellent written and verbal communication skills
  • Analytical and critical thinking
  • Strong attention to detail
  • Ability to actively listen
  • Ability to write in explanatory and procedural styles for multiple audiences
  • Experience in controlled procedural document principles, process design and leading process improvements
  • Proven ability to design/develop SOPs, supporting documents and forms/templates through writing samples
  • Awareness of GCP and GVP regulatory requirements
  • Strong leadership, organizational and project management skills
  • Demonstrates strong influencing and negotiating skills with the ability to communicate effectively at all levels of the organization
  • Demonstrates skills in problem solving, working independently and in a team environment
  • Experience using Electronic Document Management systems is preferred
  • Ability to multi-task and manage conflicting/changing priorities

Core Behavioral Competencies:
  • Leadership
  • Stakeholder Management
  • Project Management
  • Process Management
  • Strategic Thinking
  • Critical Thinking & Problem Solving
  • Integrity and Trust
  • Negotiating
  • Organizational & Political Savvy
  • Dealing with ambiguity & paradox
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