Blackwomenintech
Analytical Technical Writer
Blackwomenintech, Boston, Massachusetts, us, 02298
Job Purpose
The following information provides an overview of the skills, qualities, and qualifications needed for this role.The Vaccine R&D portfolio is growing significantly in a very competitive environment, requiring a faster and more efficient approach to vaccine development and clinical file submission.Ways of working with the Regulatory department have changed, leading to many files being generated from the business itself rather than transferring information from scientific writers to the RA department. Many 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 skill set and capacity to bring the CMC information directly into the files.Overall, it will reduce the submission lead time and hence bring vaccines to market faster.This individual will be accountable for developing phase-appropriate:Platform approaches to build control strategies (e.g., CHO-based vaccines, mRNA vaccines, etc.).Templates for each vaccine platform, ensuring templates are used, fine-tuned, and that coaching and appropriate training are provided to each SCO to ensure regulatory documents contain the appropriate details, quality, and style.Key ResponsibilitiesThe 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 for 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 reviews 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 maintain a strong link between ARD and/or potential external partners and the Regulatory function.As a member of the 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 of experience in biologics testing.Strong influencing and communication skills with an understanding of the cross-functional facets.Understands regulatory and GMP requirements, particularly in clinical development phases.Understands and knows how to manage cultural differences.Mental agility to work on multiple projects and different activities; dynamic 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 organization 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.
#J-18808-Ljbffr
The following information provides an overview of the skills, qualities, and qualifications needed for this role.The Vaccine R&D portfolio is growing significantly in a very competitive environment, requiring a faster and more efficient approach to vaccine development and clinical file submission.Ways of working with the Regulatory department have changed, leading to many files being generated from the business itself rather than transferring information from scientific writers to the RA department. Many 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 skill set and capacity to bring the CMC information directly into the files.Overall, it will reduce the submission lead time and hence bring vaccines to market faster.This individual will be accountable for developing phase-appropriate:Platform approaches to build control strategies (e.g., CHO-based vaccines, mRNA vaccines, etc.).Templates for each vaccine platform, ensuring templates are used, fine-tuned, and that coaching and appropriate training are provided to each SCO to ensure regulatory documents contain the appropriate details, quality, and style.Key ResponsibilitiesThe 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 for 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 reviews 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 maintain a strong link between ARD and/or potential external partners and the Regulatory function.As a member of the 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 of experience in biologics testing.Strong influencing and communication skills with an understanding of the cross-functional facets.Understands regulatory and GMP requirements, particularly in clinical development phases.Understands and knows how to manage cultural differences.Mental agility to work on multiple projects and different activities; dynamic 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 organization 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.
#J-18808-Ljbffr