Dr. Eileen Rojo

responsible for writing regulatory documents for oncology submissions

I write global regulatory documents for health authority submissions for oncology indications.

Responsible for writing regulatory/scientific documents for clients in the pharmaceutical industry.

•Was key medical writer, document manager, CRO/publisher liaison and project manager responsible for drafting/coordinating submissions of New Drug Application (United States), Marketing Authorisation Application (European Union) and New Drug Submission (Canada) for ARPIDA’s first major pipeline product in 2008 •Wrote and reviewed clinical study reports and protocols (Phase III clinical trials) •Gained significant experience in writing/reviewing pre-clinical and clinical (efficacy and safety) regulatory

•Responsible for writing chemistry, manufacturing, and control dossiers for submission to national health authorities in response to an upcoming clinical trial •Liaise with scientists in relevant line functions to assure timely receipt of source data for dossier preparation •Interpret scientific data and translate into comprehensible form in dossier to facilitate better understanding by health authorities •Responsible for preparing answers to health authority questions that arrive in response to dos

•Gathered scientific content for all NIBR Communications media (electronic and print) for internal and external audiences •Generated, researched, wrote, and edited articles featuring NIBR scientists and science for internal and external publication •Worked directly with Communications Managers to identify stories and provide copy as needed to populate communications vehicles •Interacted directly with scientists and upper-level research management to gather information about scientific advances

•Managed few research projects simultaneously and supervised technical assistants to ensure success of project •Presented project results in a number of internationally recognized conferences in the field of ophthalmology •Was author of several internal/external publications, one of which was peer-reviewed

• Managed research project which validated the use of an analytic tool in human cells • Used yeast, bacterial, and cell culture systems as integral molecular biology tools in validating analytic system • Presented project results in internationally recognized conferences and non-scientific events (e.g, EXPO 2000) • Published results in peer-reviewed journal in biochemistry

eukaroytic transcriptional regulation