Associate Professional Regulatory Publishing (51006803)
Company Name:-
DXC Technology
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Job Description:
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 clientÂ’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
Bachelor’s degree or equivalent combination of education and experience
BachelorÂ’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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