glaxosmithkline pharmaceuticals limited

MEDICAL WRITER

glaxosmithkline pharmaceuticals limited
Not Disclosed
1-3 Years Full Time
Bangalore, Karnataka, IN

Vacancy: Not Disclosed Posted: 3 years ago Applicants: 0
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Job Description

Roles and Responsibilities
 

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Contributes to documents and activities to be included in registration files.
  • Authors clinical regulatory documents following defined templates.
  • 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 at GSK Pharma, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
  • Works directly with diversity of roles at different levels within GSK (e.g., Asset Leads, Study Delivery 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.

We are looking for an experience individual and if you have these skills, we would like to speak to you.

  • Post-graduate degree in life sciences or equivalent expertise
  • Preferable 1 - 3 years clinical regulatory writing experience in the pharmaceutical industry
  • Possesses a good understanding of basic drug development.
  • Demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research.
  • Ability to author clinical regulatory documents following defined templates.
  • Demonstrates understanding of how to interpret and describe clinical data.
  • Understands the organization of clinical study reports and other documentation.
  • Possesses working knowledge of International Committee for Harmonization (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 English language skills (verbal and written)

Skills Required: R&D,Pharma,Biotechnology,Pharmaceuticals,Medical Healthcare,Medical Writer,Drug Development


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