Job Description

: Site Name: Bengaluru Luxor North Tower Posted Date: Nov 17 2022 Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Cons

: Site Name: Bengaluru Luxor North Tower Posted Date: Nov 17 2022 Ready to help shape the future of healthcare At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact stronger and more sustainable shareholder returns and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster accountable for impact - with clear ownership of goals and support to succeed and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Job Purpose:- The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations. Key Responsibilities:- Completes assignments independently or for more complex documents, under guidance of a mentor Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Ensures high integrity of data interpretation, following negotiation with document team. Ensures the consistency and quality level of all documents that are issued. Actively participates in all planning, coordination and review meetings. Ability to work on 2-3 assignments simultaneously. Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives. Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers). Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments. Knowledge/Education Required:- Minimum Level of Education Required - PhD or equivalent expertise (e.g., a master's degree with a minimum of 2 years' relevant experience ) Area of Specialization - Life sciences Why is it required - PhD is the minimum post graduate entry qualification required for this grade. The role will require a good understanding of complex regulatory writing processes including data interpretation & skills to communicate information to target audiences. The post graduate qualification should reflect experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience. Preferred Level of Education - PhD Why is it required - A PhD is the global industry standard for medical writers, and a significant number of the current Medical Writing department has PhDs. This reflects the experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience. Previous Experience Required Minimum Level of Job-Related Experience Required - Up to 5 years clinical regulatory writing experience in the pharmaceutical industry Why is this level of experience required - This level of experience is required to provide expertise for assigned activities and to work independently on some projects. Job-Related Experience sections above that are required for the job. Possesses a good understanding of basic drug development Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research. Demonstrates understanding of how to interpret, describe and document clinical data. Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP). Possesses necessary computer skills and general computer literacy. Excellent English language skills (verbal and written) Knowledge & Application:- The level of knowledge required will be applied to work on assignments largely independently, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The writer should be able to meet the quality standards of the global organization. The Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations. Problem Solving & Innovation:- Actively participates in document planning and review meetings. Demonstrates understanding of how to interpret and describe clinical data Raises and discusses concerns/ issues in an open and timely manner within the global Medical Writing Team Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives. Interaction:- Actively participates in document planning and review meetings. Raises and discusses concerns/ issues in an open and timely manner within the global team at GSK Establishes network of communication and continuously builds these relationships with stakeholders to facilitate efficient execution of assignment. Has ability to interpret, describe and document clinical data and discuss with team. Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives. Multi-Cultural Requirements:- The role requires interactions in multicultural settings and in diverse environments for discussion with peers, project team members and stakeholders. The role also may require interactions with co-workers who are in virtual remote teams. Impact:- The role will contribute to delivery of clinical R&D project milestones and ensures consistently high quality by doing the following: Completes assignments independently or under guidance of a mentor for complex documents Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives. Has ability to interpret, describe and document clinical data and discuss with team. Attends planning, coordination and review meetings. May make proposals for presentation of document content. At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .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. 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