Wednesday, 29 January 2014

Regulatory Associate post at PARAXEL

PAREXEL International is a leading global biopharmaceutical services provider, which continues to be a premier, trusted partner to clients who rely on the Company for expertise and flexibility, as well as the efficiencies of a worldwide infrastructure, to help them more quickly achieve their development and commercialization goals. For 30 years, PAREXEL has complemented client organizations with strategic insight, deep scientific knowledge, tactical expertise, and a wealth of experience throughout the development process.
The Company's offerings include worldwide regulatory expertise, Phase I-IV clinical research services, eClinical technologies that accelerate development, and integrated commercialization services. PAREXEL is focused on providing tailored solutions that match a client's specific needs by applying the right blend of resources and capabilities, as well as the right guidance and high level of quality needed to help them bring safe and effective treatments to patients sooner.
Job Title : Regulatory Associate
Job Description :

  • Perform publishing readiness activities including:
  • Troubleshoot and fix format and style issues in MS Word documents to ensure submission readiness standards.
  • Perform submission readiness activities including:
  • Prepare PDF source documents, including intra-document hyperlinks and bookmarks, Page rotation and PDF optimization.
  • Perform electronic publishing activities including:
  • Assign source documents to electronic publishing outlines.
  • Enter metadata.
  • Prepare to publish and publish output.
  • Create inter-document hyperlinks and bookmarks.
  • Perform paper publishing activities including:
  1. Scan and make submission ready paper documents.
  2. Create tables of contents, tables of figures and tables of tables.
  3. Split PDF output into appropriate volume sizes.
  4. Assign navigation aids such as: tabs overlays and pagination.
  5. Convert legacy documents to relevant electronic or paper output.
  6. Format and publish simple reports and submissions.
  7. Perform basic document management tasks including file transfer, storage, tracking, and archival.
  8. Maintain familiarity with current global regulatory submission standards.
  9. Maintain familiarity with departmental standard operating procedures and work instructions.
Qualifications :

Education : Bachelor's degree or equivalent in life sciences or technology-related discipline.
Experience : 0 to 4 years experience; or equivalent combination of education and experience.
How to Apply :

Interested candidates can apply online using the link below :
Click here!