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

📋 Description

• Create, review, and ensure the quality of regulatory and pharmacovigilance documents, such as PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans.

• Verify that documents are scientifically sound, comply with regulations, and are submitted within the established deadlines.

• Work collaboratively with cross-functional teams to analyze, interpret, and effectively communicate safety data.

• Serve as a reliable point of contact for clients, assisting in project execution and cultivating strong working relationships.

• Offer guidance, mentorship, and knowledge sharing to junior medical writers.

• Participate in process enhancements and the ongoing improvement of medical writing quality standards.

⛳️ Requirements

• MD, pharmacy, or a degree in Life Sciences.

• At least 2 years of experience in Medical Writing and related fields (case processing, signal detection, or risk management), preferably within a CRO environment.

• Capability to handle multiple and diverse tasks while prioritizing workload with a keen attention to detail.

• Proficiency in effectively training and mentoring Associate Medical Writers.

• Strong collaborative spirit and team-oriented attitude.

• Fluent in English; proficiency in an additional language is advantageous.

• A Master's or PhD is preferred.