Principal Medical Writer Lead

hace 4 semanas


Madrid, Madrid, España Engineeringuk A tiempo completo
Key Responsibilities:

• Acts as the medical writing expert for assigned drug projects.

• Leads the planning, development, and implementation of the content strategy of clinical submission documents.

• Drives the design of clinical submission documents in support of the Clinical Development Plan.

• Validates individual study protocol design, key messages of the clinical study report, and other clinical submission documents.

• Develops the project level data presentation strategy and messaging standards.

• Independently authors submission documents and works with assigned Writers and other submission team experts in developing and implementing the submission authoring strategy for all clinical documents.

• Works with Head Medical Writing Oncology to develop and implement authoring resource plans for all clinical submission documents of assigned drug projects.

• Maintains current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects.

• Responsible for the development of regulatory submission content strategy and leading cross-functional writing teams supporting high priority drug projects.
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