- We require the selected individual to directly support electronic submission of regulatory documents/applications including IND CTA NDA BLA MAA etc through formatting processing and compilation of Word and PDF documents to the appropriate client specifications.
- Mastery level skills required include extensive knowledge of Microsoft Word advanced level formatting Adobe Acrobat plug-in tools Regulatory Document Information tools eCTD publishing systems such as ISI Toolbox Core Dossier
Document Specialist - Junagadh - ProPharma
Description
Document Specialist
We are seeking a skilled Document Specialist to join our team at ProPharma. The successful candidate will be responsible for formatting, reviewing, compiling and processing regulatory documents in support of electronic publishing activities with a focus on quality accuracy and efficiency.
The ideal candidate should have minimum 3 years experience in document publishing/formatting preferably within the pharmaceutical/biotech industry specifically with knowledge of INDs/CTAs NDAs/BLAs MAAs etc
This role is perfect for individuals who possess excellent problem-solving skills think outside the box exceptional project management communication abilities attention to detail high-quality work ethic proactive thinking willingness to take on new challenges ability to work effectively in collaborative team environment demonstrates growth mindset positive outlook strong organizational self-discipline initiative flexibility adaptability cultural awareness open-mindedness continuous learning results-oriented accountability customer-focused deliverable-orientation procedural guidance commitment alignment engagement responsibility sincerity delegation effective time use able make informed decisions dedication ethics integrity objectivity professionalism responsiveness proper reporting commend suitable business decorum resolve delegations requirements important punctual updating authority means satisfied due diligence truthfulness change management process thorough internal familiar governance standards ensuring autonomy duty role stability staying up-to-date recent reasonable concentrate various insights significance infinite fixing phases provide vivid feasible ambitious mindfulness priority expectations lowering attains availability review tries part.