Medical Writing Expert

hace 2 semanas


Madrid, Madrid, España Engineeringuk A tiempo completo

About the Role

As a key member of our team at Engineeringuk, we are seeking a skilled Principal Medical Writer to join our team. In this role, you will be responsible for ensuring the highest quality of clinical submission documents, driving the design of these documents, and validating individual study protocol design and clinical study reports.

Key Responsibilities

  • Acts as the medical writing expert for assigned drug projects, leading the planning, development, and implementation of the content strategy for clinical submission documents.
  • Drives the design of clinical submission documents in support of the Clinical Development Plan and validates individual study protocol design, key messages of the clinical study report, and other clinical submission documents for assigned drug projects.
  • Leads the development of 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.
  • 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.

What We Offer
  • A comprehensive and competitive total reward package that comprises an excellent level of base pay, variable pay, and recognition programs.
  • Best-in-class employee benefits, supportive policies, and wellbeing initiatives tailored to support you and your family at all stages of your career.

Requirements
  • 5-6 years of experience in regulatory medical writing, with 4 years of experience in writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.).
  • Strong candidates with a Bachelor's degree will also be reviewed.
  • A thorough understanding of the overall drug development process and specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions.

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