Senior Scientific Writer
- Bengaluru, India
Site Name: India - Karnataka - Bengaluru
Posted Date: Sep 26 2019
- Contributes to documents and activities to be included in registration files.
- Authors clinical documents following defined templates.
- 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 at GSK Vaccines, thereby demonstrating the ability of promoting high scientific standards by pointing out obvious flaws and proposing (and advocates) alternatives.
- Works directly with diversity of roles at different levels within GSK (e.g., Clinical Research and Development Leader (CRDL), Project Level CRDL, Regional Medical Directors and Advisors, Study Delivery Leads (SDL), Study Data Managers (SDM), Biostatisticians, other Scientific Writers).
- Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.
- Preferable 2 - 5 years regulatory writing experience in the pharmaceutical industry or medical field is an asset.
- Educational qualifications: PHD/Masters degree or above)
- Possesses a good understanding of basic immunology and area of assigned vaccine project.
- Demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research.
- Demonstrates understanding of how to analyse and describe clinical results.
- Understands the organization of clinical study reports and scientific presentations.
- Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Possesses good working knowledge of statistical principles used in clinical research
- Possesses necessary computer skills and general computer literacy.
- Excellent command over English language (verbal and written)
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