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Senior Process Writer (Remote - GCP)

Basking Ridge, NJ 07920

Posted: 01/31/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 541403 Is job remote?: Yes Country: United States

Job Description


Job Summary:

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 Authorities.

Job Responsibilities:
  • Manage and lead 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 partners/SMEs and ensuring they are engaged in the content development/revision activities, including review and approval cycles.
  • Leading the Technical Writing of Global Development procedural documents in collaboration with functional process owner and cross-functional SME(s) by translating sophisticated cross-functional concepts to process maps and documentation ensuring any open process deviations, inspection commitments, corrective/ preventative actions and critical gaps are addressed.
  • Facilitating process mapping activities collecting 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.
  • Facilitating the adjudication of comments from documentation reviews.
  • Collaborating with Quality Managers during content development to ensure alignment with Content Standards and Lean Writing Principles.
  • Manage and Lead document review and approval workflows.
  • Chipping in to P&P improvements as applicable.
  • Maintaining project schedule, identifying and mitigating risks or issues, raising to leadership as applicable.
  • Collaborating with Global Development Training, Change Management, and GD Quality when applicable, to support process implementation.
  • 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.
Qualifications:
  • 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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