Principal Medical Writer

This is a fully remote position, open to applicants in Spain.

📋 Description

• The Principal Medical Writer I is tasked with the creation of clinical documents intended for submissions to regulatory bodies worldwide.

• This role offers strategic guidance to cross-functional project teams with minimal supervision to ensure that clinical documents (such as Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) present key data-driven clinical messages accurately and consistently, aligned with program objectives and regulatory standards.

• Responsible for writing or directing and guiding other writers to guarantee the prompt delivery of high-quality documents that are scientifically sound, logically structured, and present data with accuracy in interpretation.

• Manages the medical writing tasks for various compounds and takes the lead as the writer for specific summary documents.

• Provides mentorship to less experienced writers.

⛳️ Requirements

• A Bachelor's degree is mandatory.

• An advanced degree in a relevant scientific, clinical, or regulatory field is preferred.

• A minimum of 5 years of medical writing experience in the biopharmaceutical or CRO industry is required, or equivalent experience in clinical or preclinical development.

• Expertise in organizing and conveying clinical information is essential, with minimal supervision.

• Strong organizational, time management, and project management capabilities are necessary.

• Excellent verbal, written, and interpersonal communication skills are required to collaborate effectively within a team setting.

• A solid understanding of global regulatory requirements is essential, along with knowledge of therapeutic areas across all phases of clinical development.

• Proficiency in MS Word is required.

• Experience with an electronic document management system and templates is necessary.

🏝️ Benefits

• We are dedicated to the development of our employees through career advancement and growth opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a comprehensive rewards program.

• Committed to fostering an inclusive culture where you can genuinely be yourself.