Senior Document Quality Reviewer

2+ years

Preferred by Comapny

India

10 Nov. 25, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Role: Document Quality Reviewer (DQR)

The Document Quality Reviewer (DQR) provides essential support for the preparation and review of regulatory documents, ensuring their accuracy, consistency, and adherence to industry standards. This role involves quality checking of draft and final documents prepared by Medical Writing Services (MWS) before internal or external distribution, including copyediting, content review, and formatting. The DQR is responsible for consolidating feedback from multiple reviewers and providing a single, cohesive output to medical writers. This role also plays a crucial part in maintaining high standards across all documentation and contributing to process improvement efforts within the department.

Key Responsibilities

Supporting Activities

Perform quality control (QC) checks, including compilation, formatting, tabulation, and pagination of documents.
Conduct editorial and format QC, ensuring the documents meet high standards of presentation.
Perform data checks and assess the scientific sense and logical flow of the content.
Ensure document content adheres to FDA/EMA and other regulatory guidelines, as well as corporate or client SOPs, templates, and style guidelines.
File and archive project materials following department guidelines.
Work closely with medical writers to plan and coordinate complex QC activities.
Consolidate feedback from multiple Document Quality Reviewers (DQRs) into a single output for the medical writer.
Lead other DQRs in instances where QCs are split due to size or complexity, or when multiple documents are involved.
Provide oversight to ensure consistency and high quality across multiple QCs.
Contribute to process excellence by providing feedback during the review of departmental SOPs and guidelines.

Skills

Excellent written and spoken English proficiency.
Well-established proofreading skills with a strong attention to detail.
High level of numeracy; an understanding of statistics is an advantage.
Excellent interpersonal, verbal, and written communication skills.
A proactive and solutions-driven approach to work.
Client-focused attitude and a flexible approach to assignments and learning.
Ability to manage multiple tasks effectively, with a strong focus on prioritization.
Willingness to work in a matrix environment, valuing teamwork and collaboration.
Ability to plan and provide training to other team members.
Advanced project management skills, with experience managing team workload to meet deadlines.

Knowledge and Experience

Experience in the pharmaceutical industry and medical writing.
Knowledge of regulatory documents and ICH-GCP guidelines.
Proven experience in proofreading, quality control, and copy editing.
Advanced word processing skills, especially in Word for Windows, including creation and adaptation of document templates.
Familiarity with Adobe Acrobat and document formatting standards is advantageous.

Education

Bachelor's degree in Life Sciences/Health-Related Sciences or equivalent.

Why Join?

Opportunity to contribute to the preparation of crucial regulatory documents that influence industry standards and patient care.
Collaborative and dynamic work environment, with the chance to develop expertise in regulatory affairs and medical writing.
Room for professional growth, including leadership opportunities as you guide other reviewers and contribute to departmental improvements.
Engagement in cross-functional teamwork, gaining experience in a matrix structure and developing your project management skills.

The Document Quality Reviewer (DQR) role is integral to ensuring that all regulatory documents meet the highest standards of quality, supporting Parexel's mission to deliver exceptional results in the pharmaceutical industry.

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Senior Document Quality Reviewer

Job Description

Role: Document Quality Reviewer (DQR)

Key Responsibilities

Supporting Activities

Skills

Knowledge and Experience

Education

Why Join?

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