DXC Technology - Hiring B.Pharm / M.Pharm / Pharm.D / Life Sciences Graduates - Regulatory Publishing
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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