Senior Medical Writer

Planet Pharma; Burgos; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A global CRO seeks a motivated Senior Medical Writer for a 12-month contract. In this role, you'll prepare essential clinical and regulatory documents, lead discussions on writing strategy, and ensure compliance with SOPs. This position calls for strong project management and communication skills, making you integral to effective stakeholder communication.

Formación

• Experience as a lead writer on submission documents.
• Strong communication and leadership in cross-functional teams.
• Ability to work independently and solve challenges proactively.

Responsabilidades

• Author critical documents, including protocols, IBs, ICFs, CERs, PIPs, and regulatory submissions.
• Lead clinical writing discussions, ensuring strategy alignment and stakeholder engagement.
• Interpret and summarize clinical data for regulatory approval.

Conocimientos

Communication

Leadership

Project Management

Problem Solving

Descripción del empleo

Planet Pharma is working with a global CRO seeking a Senior Medical Writer to join on a 12-month contract.

As a Senior Medical Writer, you will be responsible for preparing critical clinical and regulatory documents, including:

• Protocols
• Investigator Brochures (IBs)
• Informed Consent Forms (ICFs)
• Clinical Evaluation Reports (CERs)
• Regulatory Submissions

Your expertise will ensure timely, clear, and accurate communication across teams and stakeholders.

Key Responsibilities

• Author critical documents, including protocols, IBs, ICFs, CERs, PIPs, and regulatory submissions
• Lead clinical writing discussions, ensuring strategy alignment and stakeholder engagement
• Interpret and summarize clinical data for regulatory approval
• Provide guidance and training to other writers
• Manage multiple assignments, prioritizing efficiently
• Ensure compliance with Fortrea and client SOPs

Required Skills

• Strong communication and leadership in cross-functional teams
• Project management expertise, driving tasks to completion
• Ability to work independently, solving challenges proactively
• Experience as a lead writer on submission documents

If you would like to discuss this vacancy further or explore your career options in confidence, please email us.

We are an equal opportunities recruitment business and agency, welcoming applications from all qualified candidates regardless of race, sex, disability, religion/belief, sexual orientation, or age. Planet Pharma provides global staffing services.