Scientific Writer in GlaxoSmithKline "P"

Responsibilities

• 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.
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