Document Quality Reviewer I

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Due to a growing portfolio, we are looking for a Document Quality Reviewer II. This role can be homebased in the UK or situated at our UK Head Office in Uxbridge. The offices are open planned and you will be working in an innovative, supportive and collaborative environment with peers and colleagues from around the world.

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.

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.

- 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 Qualifications

Education

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

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.

Experience

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

- Experience as a Medical Writer II or Senior Medical Writer who is looking to move into a purely quality review / checking position.

- 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.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!