Submission and Information Specialist

Hirdetés feladója: Career Oppurtinities
Munkavégzés helye: Budapest XI. kerület (Pest megye)
Jelentkezési határidő: 2022. április 19.
Várható kezdés: 2022. április 20.

Tata Consultancy Services (TCS) is an IT services, consulting and business solutions provider that has been partnering with the world’s largest businesses in their transformation journeys for the last fifty years. A part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries. As a top tier brand TCS is the number 1. TATA brand contributor on top of Jaguar Land Rover, TATA Motors, TATA Steel and TATA Global Beverages. TCS’s first Global Delivery Center was established in Budapest, Hungary in February 2001. Since its establishment, TCS Hungary is a strategic delivery center globally offering a broad portfolio of services such as IT; IT Infrastructure Services; Finance, Accounting & Analysis; Life Science and HR Outsourcing Services. 

Elvárások a jelölttel szemben

  • A Bachelor Degree or equivalent in Life Sciences
  • Excellent interpersonal and communication skills in English, orally & in written form
  • Good computing skills – extensive experience in MS Word, Excel, Adobe Acrobat
  • Able to handle multiple project assignments, good time management

Szükséges nyelvismeretek

  • Angol - Felsőfok, szóban és írásban

Feladatok

  • Format detailed data tables and figures and apply document formats using customized Word templates and ensure adherence to applicable regulatory (e.g., CTD) and the client's documentation standards
  • Maintain regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint) – Data Entry, Archiving, Tracking
  • Compile regulatory dossiers, format them for publishing and hand over of the dossier to publishing
  • Data entry into global regulatory systems (such as GPRS, Q&A database)
  • Perform QC activities on the deliverables
  • Collaborate with PTR coordinators/product managers
  • Publish CMC change packages in Spanish/English
  • Ensure overall submission quality
  • Mentor / train new joiners in SIS processes and standards and conduct training sessions when necessary.

 


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