When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's 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. We take our work personally, we do it with empathy and we're committed to making a difference.
The Document Quality Reviewer IIThe 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:
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.
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
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.
General
Attend departmental and company meetings as necessary.
Comply with departmental procedures, such as completion of workload trackers.
May participate in departmental or interdepartmental process improvement and training initiatives.
Evaluate routine processes and procedures to identify areas that can be eliminated or streamlined. Make recommendations on process improvements that could reduce recurring errors in documents.
Contribute to team initiatives like knowledge sharing exercises.
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.
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.
Education:
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
4+ years of relavent experience.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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