Regulatory Content Specialist

2 days ago


tiruchirappalli, India beBeeMedicalWriter Full time

Job OpportunityWe are seeking a skilled Regulatory Medical Writer to join our team.Responsibilities:Draft, review, and finalize regulatory documents such as clinical study reports and investigator brochures.Conduct literature reviews, adhere to regulatory guidelines, collaborate with cross-functional teams, and ensure accurate scientific communication.Key Skills and Qualifications:Proficiency in medical writing, familiarity with regulatory document preparation, and ability to interpret clinical data.Strong understanding of clinical study designs, statistical principles, and regulatory guidelines like ICH-GCP and FDA/EMA standards.Excellent organizational skills, attention to detail, and ability to meet tight deadlines.Collaboration and communication skills with experience working in cross-functional teams.Requirements:Advanced degree in life sciences, pharmacy, or related scientific field; PhD considered an asset.Previous experience in similar roles in pharmaceutical, biotechnology, or clinical research industries highly desirable.This role offers the opportunity to work closely with stakeholders to meet project deadlines and regulatory compliance standards.



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