Description
Medical WriterWork directly with clinical study teams, the Neuroscience medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory
documents.
Responsibilities include prepare regulatory documents on behalf of Company in
accordance to ICH guidelines, international regulations, Company standards and processes, and the
Company Writing Style Guide as applicable.
Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, addenda, errata. Investigator brochures, new drug advisory submission documents. Participate in clinical study and project team meetings to provide input regarding deliverables, timelines, and processes needed. Administer, the receipt, collation, and incorporation of review documents. Route documents for approval.
The medical writer should be familiar with ICH guidelines and the AMA Manual of Style, 10th edition. The writer will be asked to format and manage long documents with multiple review cycles and tight
deadlines.
Qualifications:
Excellent writer, good organizational and communication skills.
Strong attention to detail.
Proficiency using eDMS.
Strong analytical ability to interpret clinical data.
7 years writing exp in pharma industry.
Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or MD preferred.
Excellent writing skills, compulsive attention to detail, proficiency using an electronic document
management system, and strong analytical ability to interpret clinical data.
To find out more about Real Staffing please visit www.realstaffing.com