Document Controller - Immediate Start Document Controller - Immediate Start

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. The Document Quality Reviewer II

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.

Quality Control (QC)
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.
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.
Analyze DQR findings to identify root causes of errors and discrepancies and participate in corrective action planning

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.

May participate in departmental or interdepartmental process improvement and training initiatives.
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.
High level of numeracy ability to interpret statistical data and an understanding of clinical research concepts would be an advantage.
A flexible attitude with respect to work assignments and new learning.
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.

Bachelors degree in Life Sciences/Health Related Sciences or equivalent
~4 years of relavent experience.