Job Description

The role of the Plain Language Medical Writer has been created to support the establishment of a new capability within GSK in advance of the EU Clinical Trial Regulation. Plain Language Summaries (PLS) are a key component of GSK\xe2\x80\x99s commitment to clinical data transparency. They aim to help advance global scientific understanding, improve patient care, and build trust. The Plain Language Writer will apply principles of plain language and health literacy to the writing, proof-reading, and editing of plain language sum

maries of clinical study protocols and results summaries.

Job Purpose:

The purpose of the role of the Plain Language Medical Writer is to drive activities related to development of PLS of Clinical Trial Results across all therapy areas (Oncology, Specialty, Vaccines) in GSK. The role is accountable to drive consistent, timely and complete delivery of PLS from GSK Sponsored human subject research. The role is accountable for ensuring disclosure of PLS in compliance with laws and regulations, in collaboration with a multidisciplinary team of experts across projects. The role will support the implementation of new processes to meet regulatory requirements related to transparency of clinical studies and drive the operational delivery of PLS. The role is responsible to develop research content in simple language and ensure messages are engaging and conveyed with accuracy and clarity to a lay audience. The job-holder is responsible for maintaining consistency across materials and with style guidelines and formatting requirements; He/She will work closely with the study teams and advise them on options and alternatives where necessary and appropriate.

Key Responsibilities:

• Accountable for end-to-end delivery of PLS including development, approval, coordination of translation and disclosure of PLS of clinical study results in compliance with laws, regulations and standards/requirements.
• Drive PLS activities from Informed Consent through to sharing of PLS with study investigators and public posting on external portal.
• Drive timely, consistent and accurate delivery of PLS to external registers e.g. EU Clinical Trials Register, GSK Study Register, and to other registers, via appropriate channels, as required.
• Engage with study delivery leaders and clinical teams to create plain language summaries of active trials and summaries of results. Work with Scientific writers, Therapy areas, CROs and other cross-functional study team members to facilitate scoping, production, translation and delivery of PLS. Collaborate with a team of recognized subject matter experts to ensure quality of output.
• Collaborate with members of the patient advocacy and digital engagement committees, to ensure plain language summaries are relevant to different patient communities
• Promote consistent process for PLS writing activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements.
• Develop and execute the communication plan and developing continuous improvement mechanisms to demonstrate value in PLS content, process, and delivery.
• Provide support to mitigation of business transparency risks related to PLS and propose and implement strategies to manage the implications of these risks on the business. Support risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans.
• Proactively plan in response to changes in global Clinical Trial Disclosure and Transparency Regulations including new industry trends and translate into GSK\xe2\x80\x99s PLS strategy. Maintain GSK initiatives of building trust at the highest standards by continuous delivery of the internal process to be aligned with the external evolving requirements.
• Develop and maintain knowledge and expertise in Data Disclosure environment (Publications and Data Disclosure). Partner with key internal stakeholders to strengthen ensure that GSK practices for Policy requirements are in line with relevant internal and external requirements.

Minimum Level of Job-Related Experience Required:

• Broad scientific/ pharmaceutical industry background with 4-6 years of experience in clinical research and/or in pharmaceutical industry.
• At least 4 years of professional experience as a plain language writer/editor/scientific/regulatory writer within a professional science or health-writing/editing environment, or in journalism and/or in a similar role.
• Excellent English-language written communication skills. Demonstrated ability to translate complex health information into plain language.
• Experience writing in plain English and in using heath literacy and numeracy principles. Ability to explain complex material to a non-expert audience.
• Familiarity with guidance and standards on the design, conduct, and reporting of clinical trials.
• Ability to work collaboratively in a team environment.
• Ability to collaborate with writers, technical, and design staff
• Proven ability to manage workflow involving multiple projects and deadlines
• Proficiency in Microsoft Office applications and advanced proficiency in Microsoft Word and MS PowerPoint.

Minimum Level of Education Required:

University Scientific Degree Master or equivalent professional experience

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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\xe2\x80\x99re 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.

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