Site Name: Italy - Siena
Posted Date: Aug 2 2024
Help us get ahead of disease together with our OneDev-GRA-VX Development Projects Team Education required: Master's Degree in CTF, Pharmacy etc and/or Master Student in Regulatory Affairs
Other requirements: Able to sustain a conversation in English
Good IT skills with a focus on text editors
Honest and transparent attitude
Curious and passioned for details
Application deadline: August 9th
Duration: 6 Months
Start date: September 2024
Type: Extra-Curricular or Curricular Internship
Looking to gain valuable real world work experience and help positively impact the health of billions of people??Apply for a GSK Internship today! A GSK internship offers you the opportunity to kickstart your career – to take on a real role with genuine impact! You'll take on challenging, serious work on live projects or assignments. You'll also get to learn from us, develop your skills and gain valuable experience for wherever the future takes you.
What will you do? Context: The RA CMC Dev department drives the strategy and preparation of all the RA CMC submissions involving vaccines under development in different countries such us US, EU and others. The activities pertain to preparation of IND/CTA to support clinical developments studies and preparation of BLA/MAA for the final registration for commercialization of the vaccine in a specific country. The inter is requested to explore the possibility to use the emerging MLL/AI technologies in the preparation of a RA CMC submission.
Project intern description: The main purpose of the project is the preparation of a IND (Investigational New Drug Application) starting from information already used to prepare a BLA (Biological License Application) but using as template documents used for a different IND and the GSK AI tool. The activities are: 1) creation on an environment on the GSK repository system to collect the new documents generate via AI, identified the "source" RA documents and the "template" IND documents, feed the AI toll with the requested documents and transform the AI tool feedback in a RA document formatted for a Submission. The expected result is to have at least 1 Drug Substance dossier section generated via AI.
Competencies the intern will develop thanks to the internship experience: The main competencies the intern will develop are:
1) a well understanding of a IND/BLA CMC requirements and contents,
2) will receive an exhaustive summary of the RA process in a multinational company,
3) will be trained in all the systems used by GSK for preparation, revision and approval of RA CMC documents and
4) will be exposed to the GSK AI tool for the generation of Regulatory documents.
Let's do this! You'll find hints, tips and guidance on our recruitment process on our website –
We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis.
Apply now! Need help with your application? Please email us at ******** and let us know how we can help you. ?
Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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