Professional
1 Regulatory Publishing
Job
Description:
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
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