Job Description

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 a variety of European countries.

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

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.

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.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.