This page was automatically translated and accurateness of translation is not guaranteed. Please refer to the English version for a source text.

Document Quality Reviewer 1

Parexel International Corporation

Bengaluru, Karnataka, India

Under departmental supervision, the Document Quality Reviewer (DQR) I 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 data and content presented, identifying and fixing flaws in logic and flow, and following appropriate style guides/templates. The DQR I may provide editing support for more complex clinical documentation, with appropriate departmental supervision.

Relationships

Reports To

Medical Writing Support Services Line Management

Directly Supervises

None

Provides Work Direction to

None

Works Closely with

Medical Writers

External Relationships

Client technical 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.

Under departmental supervision, 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.

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.QualificationsEducation:

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 or 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.


2022-05-20 00:05:19


Apply to this job

Similar CRA jobs