Regulatory Medical Content Specialist

2 days ago

palakkad, India beBeeMedical Full time

Regulatory Medical Content SpecialistThe Role:As a Regulatory Medical Content Specialist, you will be responsible for creating high-quality scientific communication that adheres to regulatory guidelines. Your primary goal is to ensure the accuracy and integrity of clinical study reports, investigator brochures, and other critical documents.Drafting, reviewing, and finalizing regulatory documents requires attention to detail, strong organizational skills, and the ability to meet tight deadlines.Interpreting clinical and scientific data involves collaborating with stakeholders to meet project objectives and ensuring compliance with regulatory standards.Key Qualifications:To succeed in this role, you will need to have: Strong Scientific Writing Skills, familiarity with regulatory document preparation, and the ability to interpret complex clinical and scientific data.Advanced understanding of clinical study designs, statistical principles, and regulatory guidelines such as ICH-GCP and FDA/EMA standards.Excellent collaboration and communication skills with experience working in cross-functional teams.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant tools.Advanced degree in life sciences, pharmacy, or related scientific field; PhD or equivalent is considered an asset.Previous experience in a similar role in the pharmaceutical, biotechnology, or clinical research industry is highly desirable.

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