Publishing of eCTD, NeeS using publishing tools. ISI Tool Box, eCTD Validator, ViewPoint, PDF Utilities • Module 3 CMC baseline creation and its life cycle management using client specific tools. • Perform document-level and final quality control reviews of submission PDF files.• Create and verify bookmark structure and hyperlinks to ensure submission-readiness. Rendering Multiple documents to PDF, Creation of external links , Completion of Modules 1-5 in eCTD … Show more Publishing of eCTD, NeeS using publishing tools. ISI Tool Box, eCTD Validator, ViewPoint, PDF Utilities • Module 3 CMC baseline creation and its life cycle management using client specific tools. • Perform document-level and final quality control reviews of submission PDF files.• Create and verify bookmark structure and hyperlinks to ensure submission-readiness. Rendering Multiple documents to PDF, Creation of external links , Completion of Modules 1-5 in eCTD format.• Work with Document Coordinator to find and resolve all submission related issues.• Organize folders/files to build electronic submissions.• Create electronic media for client or submission deliverable.• Participate in the development of internal projects.• Create and deliver presentations for departmental sustainment training and new hire training.• Walk a client through the overall publishing process and an explanation of the publishing tools and tasks used to produce electronic submissions. Show less

Company Profile:Perfect Pharmaceutical Consultant Pvt. Ltd. Is 20 year old Professionally managed successful Regulatory Affairs Consultancy Company; having Worldwide presence, located in Pune. Perfect partner for outsourcing regulatory solutions (DMF & Dossiers, CTD Files, COS, Clinical & Non-clinical summary, Expert reports, Clinical & Toxicological studies, BE/BA studies)Job Profile:Compiling and reviewing Module 3 of CTD.Extensively searching and retrieving clinical and… Show more Company Profile:Perfect Pharmaceutical Consultant Pvt. Ltd. Is 20 year old Professionally managed successful Regulatory Affairs Consultancy Company; having Worldwide presence, located in Pune. Perfect partner for outsourcing regulatory solutions (DMF & Dossiers, CTD Files, COS, Clinical & Non-clinical summary, Expert reports, Clinical & Toxicological studies, BE/BA studies)Job Profile:Compiling and reviewing Module 3 of CTD.Extensively searching and retrieving clinical and Nonclinical studies for Module 4 and Module 5.Maintaining track on the CMC documentation used for Dossier compilation.Reviewing of technical documents received from different departments before including in dossier. (Such as Analytical Method Validation, Process Validation, Product Development Report, Drug Master File). Show less