Lead Medical Writer (Regulatory)

Position: Lead Medical Writer (Regulatory Focus)

Location: Remote (UK, Germany, or France)

As a Lead Medical Writer, you will be responsible for planning, drafting, and managing the review process for documents related to clinical studies and regulatory submissions. These documents may include key sections of marketing applications, protocols, clinical study reports, briefing materials, and responses to regulatory authorities. The role requires strong critical thinking skills, expertise in scientific writing, data interpretation, and a solid understanding of the regulatory content life-cycle. You will also oversee and coordinate external medical writers, ensuring all documents meet company standards, organizational objectives, and are clear, consistent, and grammatically correct.

Key Responsibilities:

• Prepare regulatory documents for NDA/MAA/IND submissions and briefing packages, adhering to regulatory guidelines and project timelines.
• Lead the creation of complex documents, such as Module 2 clinical documents, including Integrated Summaries of Safety (ISS) and Efficacy (ISE), with support from other medical writers.
• Develop content and timelines for document production and manage the review and approval process, ensuring alignment with broader project schedules.
• Review documents for clarity, scientific accuracy, consistency of content and messaging, and resolve issues with cross-functional contributors.
• Collaborate with external publishing teams to ensure accurate and timely publication of documents.
• Serve as a key participant in functional and cross-functional teams, providing strategic input.
• Contribute to continuous improvement initiatives and best practices within the medical writing and regulatory teams.
• Stay current on key regulatory, scientific, and therapeutic topics relevant to drug development.

Qualifications:

• Bachelor's degree required; advanced degree in life sciences or a related field preferred.
• Strong knowledge or experience in anti-infective or antiviral therapies is advantageous.
• Proven experience writing regulatory documents, including clinical study reports, protocols, NDA/MAA submission documents, investigator brochures, and regulatory briefing materials.
• Demonstrated ability to produce high-quality scientific writing in English.
• Excellent project management skills with the ability to meet multiple deadlines.
• Strong interpersonal, verbal, and written communication skills, with the ability to collaborate effectively with cross-functional and geographically diverse teams.
• Analytical and problem-solving skills, with the ability to think clearly and adapt to changing conditions.

Why Join Us?

• A unique culture focused on scientific excellence and collaboration, with a commitment to improving patients' lives.
• Opportunities for professional growth and development, with strong support for individual learning and career advancement.
• Flexible working arrangements that support work-life balance.
• Competitive compensation and a comprehensive benefits package.