Job Ref: 214953618

Date: 2021-10-20 09:49:28

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A Medical Writer will author regulatory, clinical trial, and medical affairs documentation, such as Module 2, CSRs, Investigative Brochures, Protocols, PIPs, Scientific Advice, and others. Additionally, the Medical Writer will contribute to medical writing knowledge to new business proposals.

Essential Functions Include:

* High-quality regulatory writing including authoring clinical summaries, briefing documents, and Paediatric Investigation Plans for EMEA submissions such as Module 2, CSRs, Investigative Brochures, Protocols, PIPs, Scientific Advice, and others.

* Represent Medical Writing on project teams and, as such, advise teams and clients on content and format requirements for various documents, as well as coordinate writing activities for document development.

* Ensure compliance, remain informed on regulations and developments in medical writing.

* Maintain knowledge of product areas, current trends, and current literature.

* Providing general scientific insight for new business pitches and proposals

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