Analytical Technical Writer
Il y a 3 mois
Job Purpose
Vaccine R&D portfolio is growing significantly and 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 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 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 support ARD submissions activities both strategically by providing guidance and operationally by drafting and reviewing related documentation. 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 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).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 5 years in managing people preferably Strong influencing and communication skills with an understanding of the cross-functional facets Understands regulatory and GMP requirements Understands and knows how to manage cultural differencesPreferred Qualifications:
If you have the following characteristics, it would be a plus:
Ph.D. or equivalent in scienceIf 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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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