Senior Medical Writer

PRA; España; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Join a leading clinical research organization as a Senior Medical Writer, where you will play a pivotal role in supporting a Top-5 pharma company. This exciting opportunity involves producing high-quality regulatory and submission documents, collaborating with Principal Medical Writers, and ensuring submission readiness. You will leverage your strong writing skills and regulatory knowledge to convert complex scientific data into clear, structured documents. If you are passionate about contributing to groundbreaking research and thrive in a dynamic environment, this role offers the perfect platform for your expertise.

Formación

• 3-5 years of experience in Medical Writing or relevant pharmaceutical experience.
• Strong writing skills to convert scientific data into clear messages.

Responsabilidades

• Produce clinical and regulatory documents in collaboration with Principal Medical Writers.
• Analyze data to determine the best approach for document composition.

Conocimientos

Medical Writing

Regulatory Knowledge

Data Analysis

Lean Writing Strategies

Communication Skills

Educación

Bachelor's Degree

Master's Degree

Descripción del empleo

Job Title: Senior Medical Writer

Join the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence, as a Senior Medical Writer.

In this role, you will support a Top-5 pharma company, helping deliver best-in-class regulatory and submission documents. You will be fully embedded with our client while being employed by ICON.

Responsibilities :

1. Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. These may include Clinical Study Protocols and Clinical Study Reports across Phase 1 to Phase 3 in multiple therapeutic areas.
2. Analyze and interpret data thoroughly to determine the best approach for document composition, applying lean writing strategies.
3. Serve as the primary contact for the study team regarding preparation and timelines of assigned documents, including planning.
4. Facilitate document reviews, ensuring they are submission-ready and approved, working closely with QC personnel and publishing specialists.

Minimum Requirements :

• Bachelor’s degree required; Master’s degree preferred.
• 3-5 years of Medical Writing or relevant pharmaceutical experience with scientific and regulatory knowledge.
• Strong writing skills with the ability to convert scientific data into clear, well-structured messages.
• Proficient in independently writing various clinical/regulatory documents, mainly CSRs and Protocols, including leading creation, coordination, review facilitation, and ensuring submission readiness.