Career opportunity for fresh B.Pharm/B.Sc as Regulatory Associate in Parexel

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Post: Regulatory Associate

Job Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
• 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:
• Scan and make submission ready paper documents.
• Create tables of contents, tables of figures and tables of tables.

• Split PDF output into appropriate volume sizes.
• Assign navigation aids such as: tabs overlays and pagination.
• Convert legacy documents to relevant electronic or paper output.
• Format and publish simple reports and submissions.
• Perform basic document management tasks including file transfer, storage, tracking, and archival.

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• Maintain familiarity with current global regulatory submission standards.
• Maintain familiarity with departmental standard operating procedures and work instructions.

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

Additional Information:
Experience: 0-4 Yrs
Location: Bangalore
Functional Area: R&D
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 10^th Feb., 2014
Req Number: pare-10030166