Clinical Content Developer

4 days ago

Pune, Maharashtra, India beBeeContent Full time ₹ 15,00,000 - ₹ 25,00,000

Job Summary

We are seeking a highly skilled Content Author to join our team. In this role, you will be responsible for creating high-quality content across various formats, including reports, documents, and other materials.

Responsibilities

  1. Authoring and Review: You will be responsible for the entire life cycle of the document, from creation to finalization. This includes maintaining quality and timeliness, as well as ensuring compliance with internal/client SOPs and regulations.
  2. Complex Document Creation: You will create end-to-end authoring of complex deliverables, including periodic aggregate reports, regulatory and safety reports, and other documents.
  3. Data Validation: You will perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document.
  4. QC Review: You will perform QC review of documents to ensure data accuracy, consistency, and compliance with client-specific style guides.
  5. Collaboration and Support: You will assist junior writers with incorporation of review comments, tracking and communication, and mentor colleagues on scientific formats required to prepare documents.
  6. Formatting and Design: You will review formatting per the client-specific style guide and format PDF documents using Adobe Acrobat and ISI Toolbox.
  7. Process Improvement: You will contribute to continuous process improvement in the team for developing content.
  8. Regulatory Compliance: You will ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines.
  9. Training and Development: You will participate in assigned training programmes relevant to the job, create, maintain and disseminate training materials and guidelines, and conduct training seminars as necessary.

Required Skills and Qualifications

  • Medical/M.Pharm/Pharm D/life sciences degree
  • 5-7 years of relevant experience

Benefits

This is a great opportunity to work with a talented team and contribute to the development of high-quality content. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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