Executive, Clinical Affairs

Position Title: Medical Writer, Clinical Development

Role Summary

The Medical Writer will be responsible for authoring, reviewing, and managing high-quality clinical and regulatory documents to support global clinical development programs. The individual will work closely with Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance, Regulatory Affairs, and external partners to ensure scientifically accurate, regulatory-compliant, and inspection-ready documentation.

Key Responsibilities

• Author and compile clinical trial documents, including:
• Clinical Study Protocols and Amendments
• Investigator's Brochures (IBs)
• Clinical Study Reports (CSRs)
• Informed Consent Forms (ICFs)
• Statistical Analysis Plan summaries
• Clinical sections of regulatory submissions
• Investigator Meeting materials and study manuals
• Safety narratives and development reports
• Ensure consistency, scientific accuracy, and compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements.
• Collaborate with cross-functional teams to gather, interpret, and present clinical data effectively.
• Manage document review cycles, incorporate stakeholder feedback, and maintain version control.
• Support health authority submissions and responses to regulatory queries.
• Develop and maintain document templates, style guides, and writing standards.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field (Master's/PharmD/MD preferred).
• 3+ years of medical writing experience in the pharmaceutical, biotechnology, or CRO industry.
• Strong understanding of clinical research, drug development, ICH-GCP, and regulatory guidelines.
• Excellent scientific writing, communication, and project management skills.
• Proficiency with Microsoft Office and document management systems.

Desired Competencies

• Scientific rigor and attention to detail.
• Strong cross-functional collaboration.
• Ability to manage multiple projects and timelines.
• Commitment to quality, compliance, and operational excellence.

Key Success Indicator

• Deliver accurate, high-quality, regulatory-compliant clinical documents that enable efficient execution of clinical trials and successful global regulatory submissions.
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Education

• Bachelors Degree (BA/BS) Science field - Required

Experience

• 5 years or more in Working with Regulatory Affairs, Technical Writing, Pharmaceutical industry or related field.

Specialized Knowledge: Licenses