kps life
Process Writer, Process & Procedures UK
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Overview
KPS Life is seeking a Global Development Process & Procedures (P&P) Process Writer to work in direct collaboration with one of our Sponsor partners. This role is responsible for facilitating and creating Global Development process documents in collaboration with Process Owners and Subject Matter Experts. This role involves leading projects to develop procedural documents, assessing the impact of document creation or updates, and ensuring alignment with content standards. The Process Writer also collaborates with various teams to support process implementation and continuous improvement initiatives.
This role is ideal for professionals with a strong background in process documentation and technical writing within the pharmaceutical or clinical development industry, seeking to contribute to the creation and improvement of global development processes.
Key Responsibilities
- Project Facilitation and Document Development: Lead projects for the development of procedural documents for global development, including assessing the impact of document creation or updates through document Impact Assessments.
- Stakeholder Engagement: Identify stakeholders and SMEs, ensuring their engagement in content development and revision activities, including review and approval cycles.
- Technical Writing and Process Mapping: Translate complex cross-functional concepts into process maps and documentation, addressing open process deviations, inspection commitments, corrective/preventative actions, and critical gaps.
- Process Mapping Facilitation: Facilitate process mapping activities, capturing process details such as scope, boundaries, inputs, outputs, process steps, and sequence, while identifying bottlenecks and redundancies.
- Document Review and Approval: Facilitate the adjudication of comments from documentation reviews and manage document review and approval workflows.
- Project Management: Maintain project schedules, identify and mitigate risks or issues, and escalate to leadership as applicable.
- Collaboration with Cross-Functional Teams: (e.g. Training, Quality, Change Management) to support process implementation.
- Contribute to Process & Procedures Improvements: Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of process documentation.
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Ideal Qualifications
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- Education: Bachelor’s Degree in a relevant field.
- Experience: 7+ years of experience in process documentation, technical writing, or related roles within a regulated environment.
- Technical Skills: Proficiency in Microsoft Visio or other process mapping tools; experience with Electronic Document Management Systems.
- Communication Skills: Excellent written and verbal communication skills, with the ability to write in explanatory and procedural styles for multiple audiences.
- Project Management: Demonstrated ability to manage multiple projects simultaneously, adhering to deadlines and ensuring all documentation is delivered on time and within compliance.
- Adaptability: Highly self-motivated, flexible, and able to follow through in an ambiguous, fast-changing environment.
- Travel: May require up to 25% travel.
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