Job Description

: Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, India - Karnataka - Bengaluru, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, Warsaw Cirrus Posted Date: Nov 9 2022 Job Purp

: Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, India - Karnataka - Bengaluru, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, Warsaw Cirrus Posted Date: Nov 9 2022 Job Purpose: Contributes to define and execute the strategy of the Global Clinical Operations Leadership Team (member of GCOLT). Accountability to deliver the key pipeline milestones related to Medical Writing. Ownership and optimize capacity management and resource allocation of the Medical Writing resources, including internal GSK workforce and alliances with functional service providers to enable flexibility. Define & implement strategy to drive high quality clinical and regulatory documents for competitive delivery of our pipeline (protocol to clinical study report [study-based documents] and cross-study documents [such as clinical summaries and plain language summaries]. These documents are the key media to provide the scope of work to clinical investigators, ethics committee and regulatory agencies. Develop a leadership culture within the global science writing platform to continuously challenge the status quo to maximize value-creation in a constantly changing environment (eg, reduce redundancy within our documents, rethink complex SOPs, processes, and templates, eProtocol, Reports, etc). Promote agility and reliability to ultimately create trust with patients (eg, eConsent, plain language summaries, investigative site involvement with protocol review, significant reduction in time to execute critical-path strategic activities that will help bring our vaccines to the market sooner through prioritizing, aligning, efficiency improvements [both system and process]) Collaborate and where appropriate lead across disciplines, business units and sometimes industry to ensure best practices/state of the art solutions to processes, systems, timelines and standards for developing our documents (Protocol structure and template) Align science writing services to continually innovate solutions to ensure we remain leaders in quality, time and efficiency for document production (eg, technical templates, software for anonymization process, system innovation such as radically rethinking how we create documents to communicate information in the digital age). Maximize opportunities of value-creation by Science Writing by alignment (eg resources, initiatives, and priorities) with other functions, Clinical, Medical Governance and Regulatory (eg, through LTs, functional meetings). Accountability for a cross portfolio view driving consistency, new approaches and take an enterprise view of medical writing outputs driving priorities, resource allocations to ensure industry leading targets are met. Responsibilities: End-to-end development of documents needed for clinical trials (protocols, clinical study reports, ICF, amendments, reports, ePublishing, etc.). Converts relevant data and information into a form that meets clinical regulatory document requirements. Coordinates reviews, approvals, and other appropriate functions involved in the production of clinical regulatory projects. Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols, confirms completeness of info to be presented and challenges conclusions when necessary. Independently resolves document content issues and questions. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs. Develops cross-study documents needed for submission to health authorities in collaboration with regulatory affairs (IBs, clinical summaries & overviews, briefing books, responses to regulators, Plain Language summaries). Provides strategic input to document content on cross-functional platforms (driving content according to external/internal stakeholder requirements/expectations and internal standards). Ensures delivery (realistic planning) of high quality clinical/regulatory documentation for vaccine programs according to business needs (standard- and expediated timelines) Leads in development of a culture to perpetually innovate new solutions and services (eg, plain language summaries, eProtocol, simplified processes [CSR sign off]). Builds capability to meet the changing business and compliance environment (disclosure of our study documents). Increases empowerment and ownership of the science writing function to create standards (eg, processes, cross-functional style guides, ePublishing requirements) for writing (including simplification) science Only complete documents can be evaluated. Strengthens transversal collaboration (lead in taskforces [ICF/protocol], cross-functional continuous improvement, IMT, facilitate knowledge transfer and sharing lessons learned). Sets direction and drives priorities for strategic, process and operational business needs. Why You Basic Qualifications: PhD educated, preferably in life sciences Solid experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry Strategic thinking and ability to execute the strategy Demonstrated leadership, ownership and accountability Ability to influence senior stakeholders and peers within the organization. Experience in multicultural settings, diverse environments with respect to dynamics of human interaction Outstanding project and people management skills Highly pragmatic with strong negotiation skills Excellent strategic, planning and organizational skills Outstanding knowledge of written and spoken English: ability to mentor and understand selection of essential information, logical flow, clarity, accuracy appropriate for target audiences. Why GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. .LI-GSK #LI-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.(.US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. 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