Medical Writing Specialist

3 days ago


Copenhagen, Copenhagen, Denmark Pharma IT Full time
Job Description

We are seeking a Senior/Principal Medical Writing Consultant to join our team. As a key member of our Regulatory Affairs & Medical Writing Team, you will work as a consultant to support our clients in the Pharma, Biotech, and Medical Device industries.

In this role, you will be responsible for writing and reviewing clinical (and nonclinical) documents for regulatory submissions in the EU and US. This includes Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety, clinical trial protocols and reports, Paediatric Investigational plans, Orphan Drug Designation applications, Investigator's Brochure, meeting requests and briefing documents, and other related documents as requested by our clients.

You will participate in answering questions from Health Authorities worldwide and write and review scientific publications and scientific presentations. Collaboration with cross-functional teams, including external stakeholders, is essential to ensure project goals, deliverables, and requirements are met.

Fostering effective communication and collaboration among project team members is crucial, ensuring clarity of roles and responsibilities. You will also ensure compliance with regulatory requirements and industry standards throughout the project lifecycle.

Evaluating project outcomes and providing recommendations for process improvements and best practices is an important aspect of this role.



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