Senior Life Sciences Document Specialist

1 day ago

surat, India beBeeRegulatory Full time

Regulatory Medical WriterDetailed information about this role can be found below.The Regulatory Medical Writer will draft, review and finalize regulatory documents such as clinical study reports, investigator brochures and other essential documents with a high level of accuracy.Excellent proficiency in medical and scientific writing is required along with familiarity with regulatory document preparation and the ability to interpret clinical and scientific data.A strong understanding of clinical study designs, statistical principles and regulatory guidelines such as ICH-GCP and FDA/EMA standards is also necessary.Effective organizational skills, attention to detail and the ability to meet tight deadlines are key attributes for success in this position.Strong collaboration and communication skills with experience working in cross-functional teams are highly valued.Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant tools is expected.An advanced degree in life sciences, pharmacy or a related scientific field is preferred; a 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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