Document Quality Reviewer Ii

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: No
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**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Detail-Oriented
- Deadline-Oriented
- Communicator
- Organized
- Versatile
- Tech-Savvy

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Work-life Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Career Development**: Opportunity to learn and grow through a performance and development goal-setting program.
- **Home based**: Love where you work, and work where you love.
- **Variety**: Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

The Document Quality Reviewer (DQR) II 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 DQR II will independently provide editing support for more complex clinical documentation.

Reports To: Department Line Management, Medical Writing Services

Directly Supervises: None

Provides Work Direction to: Junior Document Quality Reviewers

Works Closely with: Medical Writing staff

External Relationships: Client representatives

Key Accountabilities:
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 clinical components 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.

**Qualifications**: Education:
Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.

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 and 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.

Experience of safety aggregate reports a distinct advantage.

**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