Regulatory Medical Writing Expert

hace 1 día


Madrid, Madrid, España Engineeringuk A tiempo completo

Company Overview

At Engineeringuk, we pride ourselves on being the world's largest and most comprehensive clinical research organisation, driven by healthcare intelligence. Our team is passionate about advancing medical knowledge and improving patient outcomes.

 

Salary

We offer a competitive salary of $120,000 per annum, reflecting our commitment to attracting and retaining top talent in the field of regulatory medical writing.

 

Job Description

As a Principal Medical Writer at Engineeringuk, you will play a critical role in leading the planning, development, and implementation of content strategies for clinical submission documents. Your expertise will drive the design of clinical submission documents in support of our Clinical Development Plan, ensuring that individual study protocol designs, key messages, and other clinical submission documents meet the highest standards.

You will be responsible for developing project-level data presentation strategies and messaging standards, independently authoring submission documents, and collaborating with assigned writers and submission team experts to develop and implement submission authoring strategies.

In addition, you will work closely with our Head Medical Writing Oncology to develop and implement authoring resource plans for all clinical submission documents of assigned drug projects. Your responsibilities will also include maintaining current knowledge on regulatory agency medical review guidelines and drug approval requirements for assigned projects.

 

Required Skills and Qualifications

To succeed in this role, you will require:


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