Professional 1 Regulatory Publishing
Require 3 to 5 years of Regulatory
Publishing experience with the below:
§ Hands-on publishing
skills for submission and document level publishing
§ Understanding of
industry standards related to eCTD, and other variations of electronic
submissions and document publishing
§ Have working knowledge
in DXC scanning and publishing products such as TRS ToolBox, eCTDXPress, TRS
Publisher, CRFTrack and DocComposer
§ Detail oriented with
good organizational skills
§ Ability to manage
several tasks simultaneously and across multiple projects
§ Essential experience at
working both independently and in a team-oriented, collaborative environment
within a global team
§ Provide mostly document
level and some submission level publishing services to assist clients in
submission or archive related activities (i.e. conversion of paper documents to
electronic format, CRF processing, Report publishing, general PDF navigation,
MS Word formatting, etc.)
§ Identify and communicate
issues in timely manner. Provide project lead with issue logs as issues
are encountered
§ Participate in project
meetings to provide status updates and address submission related matters
§ Be available for
afterhours support to accommodate client submission schedules or provide
support for global team members
§ Provide quality and
timely deliverables to meet the client’s expectation
§ Familiar with regulatory
requirements and Health Authority guidance including ICH, FDA, EMA and other
country specific guidelines.
§ Following company rules
and standard operating procedures
§ Strong Analytical and
Problem solving skills
Basic Qualifications:
§ B.Pharmacy, M.Pharmacy,
Bachelors in Life Sciences, Biotechnology, PharmD
§ Bachelor’s degree in
life sciences specialty (pharmaceutical /biotech /diagnostic /medical device)
preferred
§ Three or more years of
regulatory publishing experience
§ Experience working with
standard publishing tools and applications
Other Qualifications
§ Good organization and
time management skills
§ Communication,
presentation and facilitation 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
§ Ability to effectively
present information and respond to questions from groups of managers, clients,
customers, and the general public
Work Environment
§ Office environment
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