Medical Document Specialist

3 days ago

nashik, India beBeeMedical Full time

Regulatory Medical Writer RoleThis is a full-time remote role for a Regulatory Medical Content Specialist. The role will be responsible for creating, reviewing, and finalizing regulatory documents such as clinical study reports, investigator brochures, and other essential documents.Proficiency in medical writing, familiarity with regulatory document preparation, and the ability to interpret clinical and scientific data.Strong understanding of clinical study designs, statistical principles, and regulatory guidelines such as ICH-GCP and FDA/EMA standards.Excellent organizational skills, attention to detail, and the ability to meet tight deadlines.Strong collaboration and communication skills with experience working in cross-functional teams.The ideal candidate should have a strong background in medical writing and a thorough understanding of regulatory requirements. Additionally, they should be able to work effectively in a team environment and communicate complex information clearly.Key Responsibilities:Create high-quality regulatory documents, including clinical study reports and investigator brochures.Review and finalize regulatory documents to ensure accuracy and compliance.Collaborate with cross-functional teams to ensure effective communication and timely delivery of projects.The successful candidate will be rewarded with a competitive salary and benefits package, as well as opportunities for professional growth and development.

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