AMAG Pharmaceuticals is seeking a Medical Writer to work in collaboration with the cross functional teams to ensure that clinical documents accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements.
The incumbent will assist in authoring investigators’ brochures, clinical study protocol and amendments, clinical study reports, and clinical documents used aspart of clinical trial applications or marketing authorization submissions and other regulatory dossiers.
Duties and Responsibilities:
• Responsible for writing and editing documents including, but not limited to, investigator brochures, integrated clinical/statistical study reports, clinical protocols and amendments, Integrated Summaries of Safety (ISS) and Efficacy (ISE), annual reports/DSURs, manuscripts and posters
• Accurately and consistently presents key clinical messages in accordance with program goals and regulatory requirements.
• Writes documents (both internal and external) to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and provide accurate data presentation and interpretation.
• Ensures final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the international conference on harmonization (ICH)
• Assists in developing strategy for organizing and preparing clinical documents for regulatory health authority submissions
• Performs quality control review of medical writing documents.
• Assists in the development of templates, style guidelines and SOPs for clinical documentation.