Regulatory Compliance Document Specialist

6 days ago


Bengaluru, Karnataka, India Parexel Full time

Job Overview:

Parexel is seeking a highly skilled Regulatory Compliance Document Specialist to provide support for the preparation of regulatory documents through the provision of document quality checking services.

Key Responsibilities:

Perform quality control checks, including compilation, formatting, tabulation, and pagination of documents.

Perform editorial and format quality control of documents.

Ensure document content and style adhere to FDA/EMA or other appropriate regulatory guidelines and comply with departmental and corporate or client SOPs, templates, and style guidelines.

Contribute towards process excellence by providing input into regular review of departmental SOPs and guidelines.

Requirements:

  • Excellent level of written and spoken English
  • Well-established proof-reading skills and high attention to detail
  • High level of numeracy and understanding of statistics
  • Excellent interpersonal, verbal, and written communication skills
  • Takes initiative and works in a solutions-driven manner
  • 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
  • Willingness to work in a matrix environment and to value the importance of teamwork
  • Ability to plan and provide training to other team members
  • Advanced project management skills and ability to manage the workload of a team to achieve common goals within agreed timelines
  • Experience in the pharmaceutical industry and medical writing
  • Knowledge of regulatory documents and ICH-GCP guidelines
  • Proof reading, quality control, and copy editing experience essential
  • Advanced word processing skills
  • Expertise in Word for Windows, including creation and adaptation of document templates
  • Knowledge of Adobe Acrobat and document formatting standards would be an advantage
  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent

Working at Parexel:

When our values align, there's no limit to what we can achieve.

At Parexel, we're committed to delivering innovative solutions that improve human health. Our team of experts works collaboratively to bring life-changing treatments to patients worldwide.

As a Regulatory Compliance Document Specialist, you'll have the opportunity to work with a talented team of professionals who share your passion for quality and excellence.



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