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Biomedical Writer and Editor
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Eirevo is looking for a skilled Biomedical Writer and Editor to join our team. In this role, you will be responsible for developing high-quality clinical trial documents, including study protocols, investigator's brochures, and clinical study reports. You will work closely with internal and external stakeholders to gather necessary input and resolve queries.
About the Role
The ideal candidate will have a strong background in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials. You will possess a deep understanding of clinical research methodologies and regulatory requirements, including ICH GCP guidelines. Your excellent writing skills and attention to detail will enable you to produce clear, concise, and scientifically accurate documents. Additionally, you will have experience in project management and coordination, with the ability to plan and manage timelines for document development.
Key Responsibilities
- Develop comprehensive study protocols that align with regulatory and ethical standards.
- Author and finalize high-quality clinical trial documents, including investigator's brochures and clinical study reports.
- Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.
- Collaborate with internal and external stakeholders to gather necessary input and resolve queries.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Strong experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.
- Deep understanding of clinical research methodologies and regulatory requirements (In-depth knowledge of ICH GCP guidelines, and compliance standards such as FDA, EMA).
- Proven track record of authoring and managing regulatory documents such as study protocols, IBs, and CSRs.
