When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Purpose:
To provide support for the preparation of regulatory documents through the provision of document quality checking services.
Accountability:
Provide medical writing review of draft and final documents prepared by Medical Writing Services the compilation, formatting, tabulation and (MWS) before internal or external distribution, including copyediting and content review.
Consolidate QCs from multiple Document Quality Reviewers (DQRs) and provide a single output to medical writers
Supporting Activities
Perform quality control (QC) checks, including the compilation, formatting, tabulation and pagination of documents.
Perform editorial and format QC of documents.
Perform data checks and ensure scientific sense and logical flow of the text.
Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs, templates and style guidelines.
Filing and archiving of project materials according to department guidelines.
Work with medical writers to plan, coordinate and execute complex QC activities.
Consolidate QCs from multiple Document Quality Reviewers (DQRs) and provide a single output to medical writer.
Lead other DQRs:
o in QCs split due to size or complexity, or
o in QCs involving multiple documents.
Provide oversight to ensure quality and maintain consistency across multiple QCs
Contribute towards process excellence, provide input into regular review of departmental SOPs and guidelines
Skills:
• Excellent level of written (and spoken) English
• Well-established proof-reading skills and high attention to detail
• High level of numeracy. An understanding of statistics would be an advantage
• Excellent interpersonal, verbal and written communication skills
• Takes initiative and works in a solutions-driven manner
• Client-focused approach to work
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
• Willingness to work in a matrix environment and to value the importance of teamwork
• Ability to plan and provide training to other team members.
• Advanced project management skills and ability to manage the workload of a team to achieve common goals within agreed timelines.
Knowledge and Experience:
Experience in the pharmaceutical industry and medical writing
Knowledge of regulatory documents and ICH-GCP guidelines
Proof reading, quality control and copy editing experience essential
Advanced word processing skills
Expertise in Word for Windows, including creation and adaptation of document templates
Knowledge of Adobe Acrobat and document formatting standards would be an advantage
Education:
