I'm a passionate medical writer with 8 years of experience in the pharmaceutical industry both in pre-clinical and clinical development. I have written several CSRs and MAA/NDA's and I am proficient in writing systematic reviews and reports of clinical trials for publication according to current standard. Disease areas I'm familiar with include oncology, neurodegenerative, respiratory, and gastrointestinal diseases. I'm a careful listener, attentive to detail, a logic mind, and I'm enjoying working with a varied group of people.
Read More »
I offer a diligent writing service for clinical documents, including CSRs, specific parts of MAA and NDA, and clinical study protocols.
I also offer consulting and writing service for query responses to agency inquiries/protocol objections and I am experienced in the writing of briefing documents in the context of scientific advice or special protocol assistance procedures.
I'm usually involving the relevant partners during the writing process (statisticians, medical director, project manager, pharmacovigilance) in order to assure a first quality control. However, once I have gathered the relevant information, I'm very independent and pragmatic in providing first-class documents, compliant with current guidelines.
In the past, I have written several CSRs, some of them being part of MAA and NDA submission. I have written parts of the non-clinical and clinical overview/summary of Module 2 of the CTD as well as responses to D120 and D180 questions.
I have written about 100 reply documents to agency inquiries regarding clinical study protocols.
I'm also offering writing service of systematic review and journal articles of clinical trials according to relevant guidelines (such as PRISMA and CASP checklist, Cochrane handbook, and specific journal requirements). I have acquired the experience and necessary skills during my Msc in international health technology assessment.
Read More »
Medical writer/ regulatory affairs
2012 - 2014
Writing of clinical study reports, MAA and NDA submissions.
Editing of clinical study protocols, Investigator Brochure, Informed Consent Forms.
Writing of regulatory documents (briefing documents,...