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DXC Bangalore Hyderabad is Hiring-Regulatory Publishing

1.00 to 6.00 Years   Bangalore, Hyderabad   25 Nov, 2021
CSC India Pvt Ltd
Job LocationBangalore, Hyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

  • 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 after-hours support to accommodate client submission schedules or provide support for global team members
  • Provide quality and timely deliverables to meet the clients 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 skill
Others Imp:-Drug development process from beginning to end-Publishing pharmaceutical developments-Good clinical practice.Experience: 4 to 7 Years of experience in Regulatory publishing.Openings: Professional 1 Regulatory PublishingWork Location: Bangalore/HyderabadQualification: B.Pharmacy, M.Pharmacy, Bachelors in Life Sciences, Biotechnology, PharmacyIndustry: Pharmaceutical & Life Sciences Functional Area: Legal & Regulatory Role Category: Corporate AffairsRole: Regulatory Affairs ComplianceEmployment Type: Full Time, Permanent ,
  • 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 after-hours support to accommodate client submission schedules or provide support for global team members
  • Provide quality and timely deliverables to meet the clients 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 skill
Others Imp:-Drug development process from beginning to end-Publishing pharmaceutical developments-Good clinical practice.Experience: 4 to 7 Years of experience in Regulatory publishing.Openings: Professional 1 Regulatory PublishingWork Location: Bangalore/HyderabadQualification: B.Pharmacy, M.Pharmacy, Bachelors in Life Sciences, Biotechnology, PharmacyIndustry: Pharmaceutical & Life Sciences Functional Area: Legal & Regulatory Role Category: Corporate AffairsRole: Regulatory Affairs ComplianceEmployment Type: Full Time, Permanent ,

Keyskills :
electronic submissionsregulatoryichscanningtoolboxlife sciencescrfematrsclinicalcollaborative environmentdigital conversionwordpublishing servicesregulatory requirementsdxcregulatory affairsproblem solvingfdastatements of work sow

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