Senior Regulatory & Scientific Writer - Remote

Overview

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

In Short

• Seeking a detailed orientated and collaborative Senior Regulatory & Scientific Writer.
• Responsible for producing high-quality scientific and regulatory documents.
• Contribute to regulatory submissions to global Health Authorities.
• 12-month maternity cover fixed-term contract with potential for permanence.
• Develop, write, and edit various scientific and regulatory documents.
• Ensure compliance with regulatory requirements and industry guidelines.
• Collaborate with cross-functional teams for accuracy of scientific data.
• Perform quality control reviews of documents.
• Conduct literature reviews and stay updated with medical guidelines.
• Maintain knowledge of regulatory writing trends.

Requirements

• Experience in regulatory and scientific writing.
• Strong understanding of regulatory requirements and industry standards.
• Excellent writing and editing skills.
• Ability to collaborate with diverse teams.
• Attention to detail and quality control.
• Knowledge of clinical and nonclinical data presentation.
• Ability to conduct literature reviews.
• Strong communication skills.
• Experience with medical communications.
• Ability to manage multiple projects and deadlines.

Benefits

• Opportunity for long-term career growth.
• Work in a rapidly growing company.
• Collaborative and supportive team environment.
• Exposure to various therapeutic areas.
• Possibility of permanent position after contract.
• Flexible working arrangements.
• Access to professional development resources.
• Engagement with global Health Authorities.
• Contribution to impactful pharmaceutical projects.
• Competitive compensation package.