Technical Writer I, Quality
Parexel International Corporation
Home Based, Any Region , South Africa
3d ago

Key Responsibilities Include some of the following : -

  • Authors, reviews, and edits Controlled Documents
  • Support the full procedure document life-cycle for Controlled Documents by serving as a Controlled Document writer and collaborating with subject matter experts and cross functional teams to ensure that their input is obtained as part of the document writing activities.
  • Ensures that documents are technically accurate and consistent regarding clarity, flow, organization, completeness, level of detail, formatting and readability across the whole document and across similar documents.
  • Verifies own work and ensures compliance to internal style guides and templates.
  • Authors, reviews, and edits written announcements of CD updates.
  • Facilitates cross-functional review and development of draft CDs and written communications, resolution of comments and feedback.
  • Drives content development for CDs through discussion with subject matter experts, aggregates information and summarizes coherently.
  • Tracks feedback, review comments and document updates.
  • May contribute to development of training materials based on CDs.
  • Tracks and manages multiple concurrent document updates including statuses, timelines, action items, and other relevant documents.
  • Translates process maps or other process representations and apply them to SOP procedures.
  • Contributes to the maintenance and updates of the SOP's through tracking spreadsheets and able to meet aggressive timelines.
  • Ensures that SOP's are released under document control requirements excellent technical standards, criteria and conventions.
  • Supports the full procedural document life-cycle for controlled documents by serving as a Controlled Document Writer.
  • Works with document owner, process owner and SME's to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across documents.
  • Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively.
  • Works with functional area SME's to develop cross-functional process models.
  • Performs other duties, as assigned.QualificationsEssential Minimum Requirements : -
  • Educated to bachelor’s degree level (technology, biological science, pharmacy, business management or operational research or other related discipline preferred) or equivalent qualification or clinical research experience.
  • Technical writing certification a plus.
  • Ideally, Lean certified or process analysis and improvement methodology training in an academic environment.
  • Knowledge and Experience :

  • Significant experience in process consultancy and / or project management or equivalent role.
  • Significant experience in CD writing or equivalent role in industry.
  • Experience working in a system for collaborative document development.
  • Process mapping understanding and experience, a plus.
  • Experience with large-scale organizational change efforts.
  • Skills :

  • Demonstrates ability to perform highly detail-oriented work in authoring, reviewing, editing and revising documents with high degree of accuracy.
  • Excellent attention to detail, particularly in in proofreading, formatting, editing and able to work with minimal supervision.

  • Excellent technical writing skills, with relevant Controlled Document writing experience.
  • Possess a solid understanding of document standards, criteria and conventions.
  • Demonstrates strong verbal, written, diplomatic and interpersonal communication skills and proven ability to work with all levels of a multinational and multicultural organization as a change agent.
  • Demonstrates ability to work independently with accuracy create draft documents, resolve comments and feedback.
  • Demonstrates ability to complete high quality work on multiple concurrent projects under tight deadlines.
  • Excellent computer skills in Microsoft Office applications.
  • Experience with document management systems, workflow development tools and Adobe Acrobat.
  • Experience working in a GxP environment. Understanding of GCP's, FDA regulations, and current industry trends is preferred.
  • Excellent analytical and problem-solving skills.
  • Knowledge of quality management systems.
  • High energy self-starter; must be able to take initiative with minimal guidance, creative at overcoming obstacles and creating results and be comfortable working both as an individual and as part of a team.
  • Well-organized, team player that works efficiently with others.
  • Displays the ability to manage customer expectations.
  • Demonstrates proactive thinking and actions.
  • Familiar with cross-functional customer service techniques.
  • Ability to multi-task in a fast-moving environment.
  • Maintain professional awareness by reading and taking an interest in business management activities outside of immediate employment.
  • Highly-motivated with a sense of urgency.
  • Good time management, multitasking and troubleshooting.
  • Client-focused approach to work.
  • Time management, planning, organization, problem-solving, innovation, self-awareness, personal leadership, decision-making, judgment, collaboration and presentation skills are beneficial and, from time-to-time, necessary.
  • Ability take ownership of assigned projects with creativity and original thought that produces successful results.
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • Excellent organizational skills.
  • Able to manage multiple and varied tasks with enthusiasm, solve problems independently, work well under pressure and prioritize workload with attention to detail.
  • 2021-03-26 01 : 00 : 47

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