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Analytical Technical Writer

3 months ago

Cambridge, Massachusetts, United States GlaxoSmithKline Full time
Site Name: Belgium-Rixensart, Italy - Siena, USA - Massachusetts - Cambridge
Posted Date: Jul

Job Purpose

Vaccine R&D portfolio is growing significantly in very competitive environment, requiring faster and more efficient approach to vaccines development and clinical file submission.

Ways of working with the Regulatory department changed leading to many files to be generated from the business itself rather than transferring information from scientific writers to the RA department. Many of the scientists in the Analytical department do not have the time and/or skills to write regulatory file sections.

This new position will increase

- The speed to develop phase-appropriate control strategy.

- The global department's skills set and capacity to bring the CMC information directly in the files.

Overall, it will reduce the submission lead time and hence bring vaccines faster to the market.

This individual will be accountable of developing phase-appropriate

- platform approach to build control strategy (eg : CHO-based vaccine, mRNA vaccines,...)

- templates for each vaccine platform and ensuring templates are used and fine-tuned as well as coaching and provide appropriate training to each SCOs to ensure the regulatory documents contain the appropriate details, quality and style.

Key Responsibilities
  • The individual is responsible for building a strategy to increase the skills and capacity of the Analytical department to a level that the CMC information can be introduced directly into CMC regulatory files. CMC analytical information consists of analytical methods, qualification and validation reports, specifications justifications, stability reporting, etc. submitted into consultation briefing documents, INDs, BLAs or equivalent files.
  • The individual will implement this strategy by educating, coaching and giving directions to GSK APLs and scientists to generate regulatory file sections with the required quality. Together with external and/or internal partners, the individual sets up training and coaching sessions for the scientists to improve their writing skills. This individual will be accountable of developing phase-appropriate templates for each vaccine platform (transversally for mRNA, viral, bacterial and adjuvants projects) and ensuring templates are used and fine-tuned.
  • To increase the overall capacity in writing CMC information, he/she will screen and select external partners and manage the third party and ensure the third party is adequately connected to the project team collaborating efficiently with Lead APLs and APLs. The individual is accountable for selecting the right partners.
  • The individual will perform review to ensure QbD principles are applied for critical CMC analytical information that is submitted. He/She might offer his/her expertise in authoring specific sections and/or in peaks of activities in close collaboration with Lead APLs and APLs.
  • The individual will drive platformization of control strategy for each vaccine platform (transversally for mRNA, viral, bacterial and adjuvants projects), linked to clinical development phase: from CQA identification to method categorization and specifications settings, including platform ATP.
  • The position will work closely with Lead APLs, Analytical Product Leads (APL), Analytical Industrialization Leads (AIL), and Regulatory Affairs. The individual will keep a strong link between ARD and/or potential external partners and Regulatory function.
  • As member of Analytical Product Leaders team, the individual might also support as APL for his/her own project (part time).


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • M.S. or equivalent in Science, Biology, Biochemistry, Chemical engineering, Bioengineering, Pharmacy or other relevant discipline
  • 10 years experience in biologics testing
  • Strong influencing and communication skills with an understanding of the cross-functional facets
  • Understands regulatory and GMP requirements, in particular in clinical development phases
  • Understands and knows how to manage cultural differences
  • Mental agility to work on multiple projects and different activitiesDynamic and able to drive change


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Ph.D. or equivalent in science
  • Broad experience and extended background in different fields such as Vx dev, analytics, regulatory

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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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