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Senior Document Quality Reviewer

India - Any Region - Home Based Date posted 09/15/2021 Job ID 72073BR

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Detail-Oriented
  • Deadline-Oriented
  • Communicator
  • Organized
  • Versatile
  • Tech-Savvy
  • "I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,
    knowledgeable, and it is easy to communicate with other staff."

    Christine, Medical Writer II
  • "Parexel makes it easy to communicate and interact with each other, which allows
    me access to expertise and knowledge beyond my own."

    Kristy, Associate Manager

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Work-life Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Career Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Home based

    Love where you work, and work where you love.

  • Variety

    Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

Responsibilities

The Principal Document Quality Reviewer (DQR) 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 Principal DQR may operate as the lead and primary client contact to manage contributions of multiple DQRs working on related QC projects. The Principal DQR also facilitates process improvement and technical mentoring/training and may support Medical Writing Services management during the sales process by providing client liaison and proposals input. Ensure that all work is complete and of high-quality.
Key responsibilities
- Lead the quality review of assigned documents. Where possible, author documents or sections of complex documents.
- Provide technical leadership to junior colleagues.
- 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 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.
- Independently produce style guides, manuals, and quality review work guides for various deliverables.
- Lead the completion of complex tasks by applying technical skills and specialized knowledge to communicate quality check findings.
- As Subject Matter Expert of DQR/QC of clinical documents, lead quality activities, set the standard for enhanced collaboration, delivery of project commitments, and customer satisfaction.
- Lead standalone QC projects. Plan and monitor the outcome of activities and negotiate on behalf of MWS. Accept or request projects to lead multiple internal and/or external team members, where you are accountable for planning, negotiation, resource allocation and strategy execution.

Skills

- 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.

Qualifications

Education:
Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.
Language Skills:
Impeccable written and verbal communication skills and strong command of the English language.
Minimum Work 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.

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