Senior Document Quality Reviewer
India, Remote Job ID R0000028752 Category Medical Writing Date Posted 11/15/2024Overview
As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful
About This Role
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:
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
#LI-REMOTE
Potential Career Path
Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Associate Medical Writer
- Medical Writer I
- Medical Writer II
- Senior Medical Writer
- Subject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
WHY MEDICAL WRITERS WORK AT PAREXEL
