Senior Consultant - Medical Writing, Clinical Pharmacology - Remote

Overview

We are looking for a Consultant (m/f/x) to support our Medical Writing activities in connection with a NDA submission. This assignment can be done remotely from the EU, UK or US (preferably East Coast).

In Short

• Collaboration with internal team members on NDA preparation by writing clinical modules.
• Support clinical pharmacology experts as lead medical writer.
• Provide project management for clinical pharmacology modules.
• Interact with non-clinical pharmacology experts and internal/external reviewers.
• Time commitment: 32h/week.
• Project duration: approximately 12 months.

Requirements

• Solid experience in writing NDA / MAA / eCTD clinical modules and clinical pharmacology / Phase 1 study required.
• Medical or science degree with substantial medical/regulatory writing experience in Biotech or Pharma.
• Native-level English proficiency.
• Strong understanding of drug development processes and regulatory interactions.
• Proficient with relevant software tools and document formatting standards.
• Excellent project management skills.
• Collaborative and proactive approach.

Benefits

• Opportunity to work remotely.
• Engage in meaningful projects in the biotech/pharma field.
• Collaborate with experts in the industry.