Senior Specialist - Labelling

Posted 28 Apr 2022

Bangalore, Karnataka - India

Req Id 246462

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


About the role

  • Create and maintain global Reference Product Information/Company Core Data Sheets, based on scientific data, for mature products in co-operation with the product teams as the basis for worldwide harmonized product labeling documents
  • Lead multi-discipline labeling teams, presenting labeling proposals and reaching consensus on proposals and presentation of labeling proposals to Labeling Decision Board for internal approval of proposed labeling
  • Oversee and support implementation of Reference Product Information/Company Core Data Sheets into local/regional labeling documents
  • Provide, upon request, analysis of competitor labeling in the relevant therapeutic area
  • Update labeling for mature products, resulting in completion of internal and external approved product labeling, including Corporate, and EU CP and MRP/DCP labeling
  • Participate in labeling negotiations with regulatory agencies and review local labeling for consistency with corporate labeling
  • Monitor compliance of locally/regionally developed labeling documents for consistency with the Reference Product Information/Company Core Data Sheet and timely submission of label (safety) changes

Impact

  • Prepare labeling that supports the safe and effective use of the product that meets the company's strategic requirements
  • Enable representatives from all major disciplines involved (e.g. Medical, GPS regulatory) to reach agreement on the best competitive labeling for the product

Complexity

  • Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs
  • The role will have to work independently on complex labeling tasks, products and cross-functional projects, and to propose solutions and strategies as part of their day to day work

Cooperation Internally

  • Global Regulatory Affairs (including regional/country regulatory departments)
  • Other Healthcare Global functions
  • Outside of the work unit, the most significant contacts are with members of the labeling working groups
  • This could include working with representatives from all of the major disciplines involved, as well as local affiliates depending on the issue

Cooperation Externally

  • Vendors
  • Global Regulatory Partners
  • External Partners

Who you are:

  • Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • 7-8 years of overall work experience in Pharma environment
  • Competent authority or Academia/R&D experience related to the role
  • Minimum 3 years of Labeling experience

 

What we offer:  With us, there are always opportunities to break new ground. 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