Senior Scientific Writer Job Vacancy in GSK Bengaluru, Karnataka – Updated today

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Full Details :
Company Name : GSK
Location : Bengaluru, Karnataka
Position :

Job Description : Site Name: Bengaluru Luxor North Tower
Posted Date: Feb 23 2022
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.
Minimum Level of Education Required
PhD or equivalent expertise (e.g., a master’s degree with a minimum of 2 years’ relevant experience)
Minimum Level of Job-Related Experience Required
Up to 5 years clinical regulatory writing experience in the pharmaceutical industry
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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