Senior Medical Writer – Regulatory

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

📋 Description

• Lead innovative projects that shape the future of clinical research.

• Produce high-quality Regulatory Medical Writing documents, including protocols, CSRs, and Investigator Brochures.

• Act as the primary author for routine documents such as clinical study reports and study protocols, while summarizing data from clinical trials.

• Review documents created by junior team members and provide training and mentorship to emerging writers.

• Ensure adherence to quality processes and specifications for assigned documents.

• Contribute to and independently formulate best practices, methods, and techniques for optimal outcomes.

• Support program management efforts by developing timelines, budgets, forecasts, and contract modifications.

⛳️ Requirements

• Bachelor's degree in a scientific field or equivalent and relevant formal academic/vocational qualification; an advanced degree is preferred.

• Prior experience that equips you with the knowledge, skills, and abilities necessary for the role (around 5+ years).

• Exceptional data interpretation and medical writing abilities, including strong grammatical, editorial, and proofreading skills.

• Robust project management capabilities.

• Extensive understanding of global, regional, national, and other document development guidelines.

• Profound knowledge in a specialized field such as preclinical, therapeutic, regulatory submissions, communications, etc.

• Familiarity with document management systems and other pertinent applications (e.g., Excel, Outlook).

🏝️ Benefits

• Competitive remuneration.

• Annual incentive plan bonus.

• Healthcare coverage.

• A variety of employee benefits.

• Flexible working culture.

• Work-life balance.