Medical Writer – Client Aligned

This is a fully remote position, open to applicants in Spain, +4 more states.

📋 Description

• Compose and revise clinical and regulatory documents, such as clinical study reports, protocols, investigator brochures, and regulatory submissions.

• Partner with cross-functional teams to collect essential information and guarantee document accuracy and completeness.

• Ensure documents are in accordance with regulatory standards, company policies, and industry best practices.

• Oversee timelines and deliverables for assigned projects.

• Remain up-to-date with industry trends, guidelines, and regulatory requirements.

• Facilitate delivery through Structured Content Authoring systems and automation.

⛳️ Requirements

• A bachelor's degree in a scientific field or an equivalent and relevant formal academic/vocational qualification is required.

• A minimum of 3 years of experience in regulatory writing.

• Experience in the pharmaceutical or CRO industry is mandatory.

• Familiarity with Structured Content Authoring systems and automation is preferred.

• An advanced degree is preferred.

• Experience with EU CTR is preferred.

• Exceptional organizational and program management abilities.

• Comprehensive knowledge of regulatory guidelines and drug development processes.

• Strong interpersonal and communication skills.

• Understanding of quality control processes and regulatory compliance.

• Self-motivated and adaptable.

• Excellent judgment with a high level of independence in decision-making and problem-solving.

🏝️ Benefits

• An award-winning learning and development program.

• Competitive salary.

• A comprehensive benefits package focused on employee health and well-being.

• A flexible working culture.

• Emphasis on work-life balance.

• A collaborative environment.

• Opportunities to share expertise and collaborate with global colleagues.