Job Details

A company is looking for a Senior Regulatory Medical Writer to lead and manage the writing of clinical regulatory documents.Key ResponsibilitiesCollaborate with internal teams to write and manage clinical regulatory documentsCoordinate review cycles and lead data interpretation and comment resolution meetingsEnsure compliance with regulatory standards and conduct quality control reviewsRequired QualificationsBachelor's Degree required; advanced degree preferredA minimum of 5 years of experience as a medical writer in the pharmaceutical industryExperience with regulatory documents such as clinical study reports and marketing applicationsSolid knowledge of FDA, EMA, and ICH guidelinesTechnical proficiency with Microsoft Office, Adobe Acrobat, and document management systems