Resume

Experience

2008-Present
Freelance

Medical Writing Consultant

Freelance Writer and Translator offering a range of multi-lingual medical writing, content writing, proofreading, linguistic consulting services and translation services to clients across multiple sectors.

2003-2011
GIMEMA Foundation

Project Manager/Regulatory Affairs Coordinator

Oversaw and led the development of protocol review documentation and obtained approval from Italian regulatory agencies and Independent Review Boards. Worked in close collaboration with global pharmaceutical firms including Sigma-Tau, Celgene, Pfizer, Novartis and Bristol-Meyers Squibb, among others, to negotiate study contracts and coordinate funding for multiple research clinical trials.

2001-2003
EORTC

Administrator of the Protocol Review Committee

Coordinated the collaborative writing of clinical research protocols for non-profit studies in the field of oncology run across Europe.

Memberships

European Medical Writers Association

Member since 2011; Member of EMWA's Medical Devices Special Interest Group; Member of EWA's Professional Development Committee

International Association of Translators and Editors in Medicine and Applied Sciences (TREMEDICA)

Member since 2011

The Italian National Association of Translators & Interpreters (AITI)

Member since 2012

Career Highlights

A multinational medical devices company in the field of orthopaedics needed support to produce clinical evaluation reports (CERs), Summaries of Safety and Clinical Performance (SSCPs) and Post-Market Clinical Follow-up Plans (PMCF Plans) on their products. Engaged as medical writer to write these documents both according to MedDev 2.7/1 revision 4 and to the European MDR. Analysed client materials; researched the scientific literature; wrote clinical evaluations, SSCPs and PMCF Plans (>15) in collaboration with the client for different devices; and supervised the drafting of additional CERs under MDD and MDR written by other suppliers. Succeeded in delivering accurate and quality reports in a timely manner.

A Biotech developing a device in the field of vascular surgery needed support to produce MDR documentation including CER, SSCP, PSUR, PMS Plan on their product. Engaged as medical writer, Analysed client materials; wrote the said documents in collaboration with internal team. Delivered in a timely manner quality documents.

A leading pharmaceutical company required support to be provided to clinicians involved in writing a literature review in the field of oncology (NSCLC). Researched the scientific literature; selected most appropriate publications; extracted most relevant data; reviewed and edited the manuscript following the instructions for authors. Succeeded in continuously liaising with authors to produce a relevant review that fills a gap in the present scientific literature.

Education

  • Medical Writing Advanced & Foundation Certificate European Medical Writers Association (EMWA)
  • Medical Devices continuous professional education 'Performance Evaluation of IVDs' (LS Academy); ‘Medical Device Software: Complying with the MDR & FDA Regulations’ (Management Forum); ‘Understanding Clinical Evaluations’ (MDTI); ‘Literature Reviews for Medical Devices’ (EMWA); ‘How to write a Clinical Evaluation Report from MDR Perspective’ (LS Academy); ‘Management of claims and post-market vigilance within the Medical Devices industry’ (EMWA); as observer and supervisor ‘Writing Clinical Investigation Plans’ (EMWA); Symposium ‘MedDevDay’ (LS Academy); Symposium ‘Medical Devices and Technologies – Emerging Opportunities for Medical Writers’ (EMWA); ‘Basics of Writing for Medical Devices’ (EMWA); ‘Device drug and drug device combination products in the EI under the Medical Devices Regulation’ (LS Academy)
  • Pharma continuous professional development ‘Manuscript Writing: from Good to Excellent’; ‘From Clinical Study Report to Manuscript’; ‘Clinical study reports – Mastering the Essential Skills’; ‘Manuscript Writing’.
  • Bachelor’s degree in Translation & Interpreting University of Alicante (Spain)

Regulatory Writing Skills

Clinical Evaluation Reports

95%

SSCPs & PMCFs

85%

Clinical Study Protocols

95%

Patient Information sheets

90%

Medical Communications Skills

Manuscripts

85%

Lay audience materials

70%

Marketing brochures

75%

White papers

75%

Training materials

95%

Slide Decks

80%