Principal Document Quality Reviewer

The Principal Document Quality Reviewer

The Principal Document Quality Reviewer ( will conduct document quality review of medical writing deliverables and ensure timely delivery of error-free, high-quality clinical documents by correcting errors in grammar, style, syntax, and format ensuring accuracy of the clinical data and content presented, identifying and fixing flaws in logic and flow, and following appropriate style guides/templates. The Principal DQR may operate as the lead and primary client contact to manage contributions of multiple DQRs working on related QC projects. The Principal DQR also facilitates process improvement and technical mentoring/training and may support Medical Writing Services management during the sales process by providing client liaison and proposals input.

Quality Control

• Ensure that all work is complete and of high-quality.

• Edit clinical documents by checking language, grammar, technical terminology, accuracy of data and scientific content.

• Confirm consistency and integrity across the document.

• Perform format changes to documents based on guidelines.

• Ensure that the document adheres to specified style guides or client conventions.

• Independently perform quality review of assigned documents (e.g. patient narratives, informed consent forms, disclosure documents, protocols, clinical study reports, investigator brochures, summary documents, regulatory responses, etc.).

• Formally document quality review findings for assigned documents using department specific procedures.

• Identify and immediately escalate any significant findings.

• Participate in resolution of findings with the document authors, and other team members, if necessary.

• Analyze DQR findings to identify root causes of errors and discrepancies and participate in corrective action planning.

• Independently produce style guides, manuals, and quality review work guides for various deliverables.

• Lead the completion of complex tasks by applying technical skills and specialized knowledge to communicate quality check findings.

• As SME of DQR/QC of clinical documents, lead quality activities, set the standard for enhanced collaboration, delivery of project commitments, and customer satisfaction.

• Lead the quality review of assigned documents. Where possible, author documents or sections of complex documents.

• Provide technical leadership to junior colleagues.

Training Compliance

• Attend and complete mandatory, corporate, project-specific, and departmental training as required.

• Keep abreast of professional information and technology through workshops and conferences (when approved) and assure appropriate transfer of that information to the department.

• Provide guidance to new staff as well as less experienced staff.

General

• Attend departmental and company meetings as necessary.

• Comply with departmental procedures, such as completion of workload trackers.

• May participate in departmental or interdepartmental process improvement and training initiatives.

• Contribute to SOP/process updates, or present at an external conference to sharpen domain expertise.

• Evaluate routine processes and procedures to identify areas that can be eliminated or streamlined. Make recommendations on process improvements that could reduce recurring errors in documents.

• Help with the generation and update of QC specific checklists and job aids.

• Contribute to team initiatives like knowledge sharing exercises.

• Lead standalone QC projects. Plan and monitor the outcome of activities and negotiate on behalf of MWS.

• Accept or request projects to lead multiple internal and/or external team members, where you are accountable for planning, negotiation, resource allocation and strategy execution.

• Stay abreast with latest tools and technology that can aid QC automation. Be part of User Acceptance Testing of new tools.

• Assist management in reviewing proposals for QC work, provide input into budgeting for such tasks.

• Act in an oversight capacity for QC-related activities, or deputize for the QC Group Lead as required.

Skills

• Impeccable written and verbal communication skills and strong command of the English language.

• Ability to deliver consistently high-quality output.

• Well-established proof-reading skills and ability to pay rigorous attention to detail.

• Demonstrate excellent interpersonal skills and proactivity.

• Take initiative and work in a solutions-driven manner.

• High level of numeracy, ability to interpret statistical data and an understanding of clinical research concepts would be an advantage.

• 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 with attention to detail.

• Willingness to work in a matrix environment and to value the importance of teamwork.

Knowledge and Experience

• Experience in the pharmaceutical or clinical research organization industry and medical writing.

• Knowledge of regulatory documents and ICH-GCP guidelines, understanding of clinical research, and the drug development process.

• Proof reading, quality control or copyediting experience.

• Advanced word processing skills, including MS Office; software and systems knowledge or ability to learn and adapt to various IT systems; document management systems, collaborative authoring and file conversion and databases.

• Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.