Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 23 2022
How can we tailor medical treatment on a global scale? 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. Proposed Job Title - Senior Medical Writer Line Manager Job Title - Function Manager, Medical Writing 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 analyzed 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 Previous Experience Required Minimum Level of Job-Related Experience Required -Up to 5 years clinical regulatory writing experience in the pharmaceutical industry 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)

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 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.

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