Job title: Clinical Transparency – Plain Language Medical Writer
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Nombre del s tio: Bengaluru Luxor North Tower Fecha de publicaci n: Mar 4 2022 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
Job Description : Nombre del s tio: Bengaluru Luxor North Tower Fecha de publicaci n: Mar 4 2022 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 (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role. 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’s 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. Knowledge/Education Required Minimum Level of Education Required Area of Specialization Why is it required University Scientific Degree Master or equivalent professional experience Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences Need to understand the science behind the documents (protocol/results/study reports) (be able to participate in specialized scientific discussions) To be able to successfully interact with many diverse and global business teams in development, translation and distribution of Plain Language Summaries. Need to be able to acquire knowledge in an independent and fast manner (Dependable self-starter). Need to be able to handle complex governance questions in a corporate setting. Preferred Level of Education Area of Specialization Why is it required University Scientific Degree Master or equivalent professional experience Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences Additional professional certification in science journalism, medical writing, or plain language writing is an asset Need to understand the science behind the documents (protocol/results / study reports) (be able to participate in specialized scientific discussions) To be able to successfully interact with many diverse and global business teams in development, translation and distribution of Plain Language Summaries. Need to be able to acquire knowledge in an independent and fast manner (Dependable self-starter). Need to be able to handle complex governance questions in a corporate setting. Previous Experience Required Minimum Level of Job-Related Experience Required Why is this level of 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. The job-holder will interact with many different functions across GSK as well as with external stakeholders position holder needs to understand intimately the business needs and operating environment across the entire development organization legislation is complex and continually evolving. List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. Excellent team-working and demonstrated leadership skills with an ability to work with a high degree of independence. Demonstrated leadership on cross-functional projects. Experience in reviewing existing business processes and devising and implementing process improvements. Experience of working within complex matrix organisation on a global scale and building relationships across multiple functions and organizational boundaries. Ability to manage conflicting demands and priorities in a high pressure, constantly changing environment. Demonstrated problem solving and analytical ability to resolve a variety of complex issues. Act as a role model in line with GSK core values and behaviours. Nuestro objetivo es ser una de las empresas de atenci n m dica m s innovadoras, de mejor desempeo y m s confiables del mundo. Creemos que todos aportamos algo nico a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es incre ble. nase a nuestra aventura en GSK donde se inspirar para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo. Aviso importante a las empresas o agencias de empleo GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo est n obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorizaci n previa por escrito antes de recomendar a cualquier candidato a GSK. La obtenci n de autorizaci n previa por escrito es una condici n precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorizaci n por escrito, se considerar que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no ser responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendaci n por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.
Location: Bangalore, Karnataka
Job date: Sun, 06 Mar 2022 23:12:53 GMT
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