
Regulatory Medical Content Specialist
1 day ago
Job Description:
The Global Regulatory Medical Writer plays a critical role in the development and submission of clinical regulatory documents. This includes writing, editing, and formatting complex documents such as study reports, protocols, and investigator’s brochures.
Responsibilities include:
- Writing and editing clinical regulatory documents
- Providing basic-level oversight and guidance for direct medical-writing support
- Resource management for clinical research documentation used in drug development and product registrations
- Compiling, analyzing, and summarizing data from various sources
- Conducting proofreading, editing, and document formatting
- Ensuring documents are accurate, complete, and adhere to regulatory guidelines and departmental standards
Required Skills and Qualifications:
To be successful in this role, you will need:
- Bachelor's or Master's degree in life sciences or related field
- Minimum 5 years of relevant experience with an advanced degree preferred
- Proficiency in writing protocols, protocol amendments, clinical study reports, and investigator’s brochures
Benefits:
This role offers opportunities for growth and professional development. You will have the chance to work on complex projects, develop your skills, and contribute to the success of our organization.
Travel Requirements:
This position requires occasional travel (up to 10% of the time). You should be able to adapt to changing circumstances and travel requirements.
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