Established in the year 1924 in India GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 3500 people. Globally, we are a £ 26.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders with a turnover of Rs. 3021 crore and a share of 4.2%*. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post: Scientific Writer
Job Description
- Writes clinical and epidemiology documents (protocols, ICFs, reports etc) to be included in registration files.
- Assists in updating clinical sections of Investigator Brochures (IBs).
- Demonstrates technical writing skills to effectively participate in the preparation of study reports and regulatory submissions.
- Ensures the consistency and quality level of all documents that are issued requiring minimal quality check (QC) mandated rework.
- Demonstrates skills in effectively managing assigned projects (including multiple priorities and responsibilities) and assures assigned milestones are achieved within the established time frames.
- Identifies operational discrepancies between protocols and report drafts and suggests alternatives or obtains clarifications, as appropriate.
- Recommends the presentation of data in study reports and takes an active role in doing so with a solid understanding of scientific methodology in the design, conduct and interpretation of research.
- Ability to ensure that all necessary components for each clinical study report are in place in order to ensure the smooth authoring of report drafts; participates in pre-and post-analysis meetings
- Ensuring high scientific integrity of data interpretation, following negotiation with internal partners.
- Assures that the team has appropriate ongoing and summary information on study document progress and results, raises concerns /issues in a timely, open and appropriate manner
- Works with vast diversity of roles at different levels within GSK. Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in project delivery
Candidate Profile
- Post-graduate degree in life sciences or medical background or equivalent expertise
- A minimum of 2 years experience in scientific/publication writing.
- Proficiency in basic immunology and area of assigned vaccine project.
- Demonstrates advanced knowledge of scientific methodology in the design, conduct and description of clinical research.
- Demonstrates expertise in analyzing and describing clinical results.
- Understands the organization of clinical study reports and scientific presentations.
- Possesses advanced knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Possesses advanced knowledge of statistical principles used in clinical research
- Possesses very good computer skills and general computer literacy.
- Excellent command over English language (verbal and written).
Additional Information
Qualification: PG in life sciences
Functional Area: Scientific Writing
Location: Bangalore
Last Date: 20th March, 2014
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