Analyst - Document Support & Training (Global Regulatory Affairs)

Posted 12 May 2019

Bangalore SBS, Karnataka - India

Req Id 192063

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


 

PURPOSE OF THE POSITION

Analyst – Document Support & Training supports the Global Regulatory Affairs Operations team of Healthcare business.

 

KEY TASKS AND RESPONSIBILITIES

  • Formatting of documents for all disciplines and all products acc to SOP02-RT11-v01 - Technical Submission Readiness of Submission Relevant Documents
  • Creating and updating Virtual Documents (“Digital Dossier”)
  • Creating and verifying bookmark structure and hyperlinks to ensure submission-readiness
  • Supporting stakeholders with need literature via ordering at Scientific Library, formatting, uploading, approving
  • Report publishing for all safety reports, clinical safety management plans as well as nonclinical reports via eldorado publishing tool
  • Point of contact for supporting all stakeholders in eldorado questions
  • Running reports in RIMS for PSMF, changing them from excel to pdf
  • Hands on experience on tools such as eCTD Xpress, ISI Publisher, ISI toolbox for the eCTD, NeeS, Paper Dossiers preparations, validation of dossiers for Health Authorities using tools such as EURs, Lorenz eValidator and handling of validation errors
  • Being able to independently resolve routine issues and most complex issues with minimal guidance
  • Assuring that submission documentation meets registration needs and timelines
  • Regular communication with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction.

 

BASIC QUALIFICATIONS

 Education:

  • Degree in a Life Science or related discipline.
  • Understanding of the Regulatory Operations area, including process and technology
  • Excellent spoken and written English.

Professional skills and experience:

  • Ability to handle software and databases needed to support the regulatory function according to the role.
  • Excellent knowledge of Microsoft Office
  • Excellent knowledge of electronic Document Management Systems

Personal skills and competencies:

  • Ability to work in teams and positively influence team spirit
  • Result orientation and willingness to take ownership
  • Strong customer orientation
  • Strong communication skills

  

 


What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com
 

Apply Now

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