Medical Writer

The Medical Writer is responsible for medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. This will be achieved by applying analytical skills, functional literacy and expertise in document preparation.

RESPONSIBILITIES:

• Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.

• High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.

• Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. 

• Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders.

• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.

• Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.

• Manage contract writers, as well as internal writers.

• Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses.