Expert Scientific Writer Job Vacancy in GSK India – Updated today

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Full Details :
Company Name : GSK
Location : India
Position :

Job Description : Site Name: India – Prestige Trade Tower
Posted Date: Feb 23 2022
Job Purpose
The Medical Writing Manager is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement. He/she has the ability to plan and prioritize without supervision.
Key Responsibilities
Proven track record in writing 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.
Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
Demonstrated effectiveness in management of projects of increasing scope and complexity.
Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
Review reporting and analysis plans and provides critical input on the content and display of tables.
Familiarity with approaches to expedite document preparation such as review tools and automation.
Can mentor junior writers
Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
Effectiveness in both oral and written communications.
Minimum Level of Education Required
PhD or equivalent expertise (e.g., a master’s degree with relevant experience)
Minimum Level of Job-Related Experience Required
Preferably at least 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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