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Associate Professional Regulatory Publishing

2.00 to 4.00 Years   Hyderabad   17 Mar, 2020
DXC Technology
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

SummarySupports development and delivery of submissions, notices and electronic submission forms as required by Food and Drug Administration and International Standards Organization regulations.Essential Job Functions

  • Provides publishing support for regulatory submissions within the life sciences industry. Includes document level and submission level publishing, archive activities, report publishing, general PDF navigation, conversion of paper documents to electronic format, and paper submissions.
  • Supports electronic communication and submission processes including general correspondence, reports and amendments. Provides quality and timely deliverables to meet the client s expectations.
  • Supports end-to-end publishing services which may include lifecycle management. Works independently with minimal supervision on common publishing tasks.
  • Develops understanding and maintains knowledge of appropriate standard operating procedures (SOPs), regulations, and policies. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
  • Provides regularly scheduled status on project metrics including hours spent, publishing efforts, etc. to the necessary project stakeholders both internally and externally.
  • Builds knowledge of company and client regulatory publishing process, updates to regulatory authority guidelines, and software updates to ensure currency and compliance.
Basic Qualifications
  • Bachelors degree or equivalent combination of education and experience
  • Bachelor s degree in life sciences specialty (pharmaceutical /biotech /diagnostic /medical device) preferred
  • Zero or more years of regulatory publishing experience
  • Experience working with standard publishing tools and applications
Other Qualifications
  • Basic communication, presentation and facilitation skills
  • Organization and time management skills
  • Ability to write reports, business correspondence, and project plans
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations
Work Environment
  • Office environment
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Keyskills :
sql insurance sla auditing projectmetrics softwareupdates digitalconversion publishingservices generalcorrespondence regulatorysubmissions businesscorrespondence internationalstandards usinessrequirementstimemanagement

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