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.
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.
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