Principal Medical Writer – Regulatory Focus

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

📋 Description

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

• Provides strategic guidance to cross-functional project teams with minimal oversight, ensuring that clinical documents effectively and consistently convey key data-driven clinical messages.

• Writes or leads other writers to guarantee the prompt delivery of high-quality documents that are scientifically sound, logically structured, and present data accurately.

• Manages the medical writing activities of multiple compounds and acts as the lead writer for specific summary documents.

• Oversees medical writing projects, which includes developing timelines and communicating with cross-functional team members to ensure awareness of review cycles and expectations.

• Reviews additional documents related to the assigned project(s) as necessary.

• Engages in cross-functional process improvement initiatives.

⛳️ 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 sector is required, or equivalent experience within clinical or preclinical development.

• Proficiency in organizing and conveying clinical information with minimal oversight is essential.

• Strong skills in organization, time management, and project management are required.

• Excellent verbal, written, and interpersonal communication skills are necessary to function effectively in a team environment.

• A solid understanding of global regulatory requirements is needed.

🏝️ Benefits

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

• supportive and engaged line management;

• technical and therapeutic area training;

• a peer recognition and total rewards program.

• We are committed to fostering an inclusive culture – where you can truly be yourself.