Document Specialist

 Posted 2 hours ago
  
 India
  
2-5 years experience
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AI Summary

Manage the technical preparation and publishing of clinical submission documents to meet client and regulatory standards. Ensure document accuracy, completeness, and compliance with electronic submission requirements while maintaining document repositories.
Document Specialist - India

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


We are currently seeking a Clinical Document Specialist to join our diverse and dynamic team. As a Clinical Document Specialist at ICON, you will play a pivotal role in providing services that support the technical aspects of the report-level document production for the clinical authoring community.

What you will be doing

  • Manage the technical preparation of submission documents (individual documents and compound documents).
  • Meet client document standards regarding formatting, timeliness, and submission readiness.
  • Provide publishing services of documents using industry standard publishing tools, including submission-ready formatting, hyper-linking, and bookmarking.
  • Review documents for legibility, format, completeness, and accuracy according to electronic submission standards.
  • Provide document management services including management of documents in a submissions document repository in accordance with quality standards.
  • Independently plan and execute assignments.

Your profile

  • Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field.
  • 1 to 3 years in document production, publishing, or similar operations roles.
  • Proficiency in submission-related Health Authority (HA) and industry regulations and guidelines, as relevant.
  • Knowledge of publishing software, electronic document management systems, and intra- and inter-document linking.
  • Strong word-processing skills and proficiency with MS Office and Adobe Acrobat. Knowledge of templates and complex document formats.
  • Strong organizational skills and attention to detail, with the ability to manage multiple tasks and priorities effectively.
  • Excellent communication and interpersonal skills, with the ability to collaborate with stakeholders at all levels of the organization.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

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