GSK GlaxoSmithKline Senior Scientific Writer Medical and Clinical Bangalore
R&D, India
Key Role:-
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.
Experience Required:-
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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