Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 25 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Azza G.

Germany

USD 25 /hr

Medical Regulatory Writer and Editor, Clinical Evaluation Specialist

Profile Summary

Ph.D. trained clinician with expertise in bone biology, inflammation, and osseointegration. Established a career as a medical writer three years ago. Proficient in performing MDR compliant clinical evaluations and systematic literature reviews using various reference management softwares. Recently completed an advanced clinical research training focusing on monitoring visits, study design and regulatory affairs. Experience in developing research and clinical protocols for therapeutics and in vitro diagnostics. Excellent written and verbal communication skills with over 12 peer-reviewed publications. Experience in managing cross-functional projects with teams of clinicians, regulatory affairs professionals, and AI engineers.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Human Biology
• ☆ Dentistry
• ☆ Oral Pathology
• ☆ Dental Research
• ☆ Prosthodontics
• ☆ Dental Surgery
• ☆ Orthodontics
• ☆ Implantology
• ☆ Regulatory Affairs
• ☆ Inflammation

Services

• Writing
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting

Data & AI Image Analysis, Data Cleaning, Data Processing, Data Insights

Work Experience

Lead Medical Writer/Clinical Evaluation SPecialist

Giotto

April 2021 - June 2023

Education

PhD

University of Toronto

May 2004 - April 2010

Certifications

• Certified Clinical Research Associate

  Pharamaakademie

  March 2021 - Present

Publications

JOURNAL ARTICLE

Frank Schulze, Gramoun A, Crowe LA, Dienelt A, Akcan T, Hofmann H, Jean-Paul Vallée, Georg Duda, Ode A (2015). Accumulation of amino-polyvinyl alcohol-coated superparamagnetic iron oxide nanoparticles in bone marrow: implications for local stromal cells . Nanomedicine (London, England).

Sakulkhu U, Lionel MAURIZI, Morteza Mahmoudi, Motazacker M, Vries M, Gramoun A, Ollivier Beuzelin MG, Jean-Paul Vallée, Rezaee F, Hofmann H (2014). Ex situ evaluation of the composition of protein corona of intravenously injected superparamagnetic nanoparticles in rats . Nanoscale.

Frank Schulze, Dienelt A, Sven Geissler, Paul Zaslansky, Janosch Schoon, Henzler K, Guttmann P, Gramoun A, Crowe LA, Lionel MAURIZI, et al. (2014). Amino-polyvinyl alcohol coated superparamagnetic iron oxide nanoparticles are suitable for monitoring of human mesenchymal stromal cells in vivo . Small (Weinheim an der Bergstrasse, Germany).

Gramoun A, Crowe LA, Lionel MAURIZI, Wolfgang Wirth, Tobalem F, Grosdemange K, Coullerez G, Eckstein F, Marije Koenders, Van den Berg WB, et al. (2014). Monitoring the effects of dexamethasone treatment by MRI using in vivo iron oxide nanoparticle-labeled macrophages . Arthritis research & therapy.

Lionel MAURIZI, Sakulkhu U, Gramoun A, Jean-Paul Vallée, Hofmann H (2014). A fast and reproducible method to quantify magnetic nanoparticle biodistribution . The Analyst.

Gramoun A, Azizi N, Sodek J, Heersche JN, Nakchbandi I, Manolson MF (2010). Fibronectin inhibits osteoclastogenesis while enhancing osteoclast activity via nitric oxide and interleukin-1β-mediated signaling pathways . Journal of cellular biochemistry.

Gramoun A, Goto T, Tommy Nordström, Rotstein OD, Grinstein S, Heersche JN, Manolson MF (2010). Bone matrix proteins and extracellular acidification: potential co-regulators of osteoclast morphology . Journal of cellular biochemistry.

Nilforoushan D, Gramoun A, Michael Glogauer, Manolson MF (2009). Nitric oxide enhances osteoclastogenesis possibly by mediating cell fusion . Nitric oxide : biology and chemistry.

Gramoun A, Shorey S, Bashutski JD, S. Jeffrey Dixon, Sims SM, Heersche JN, Manolson MF (2007). Effects of Vitaxin, a novel therapeutic in trial for metastatic bone tumors, on osteoclast functions in vitro . Journal of cellular biochemistry.

Trebec DP, Chandra D, Gramoun A, Li K, Heersche JN, Manolson MF (2007). Increased expression of activating factors in large osteoclasts could explain their excessive activity in osteolytic diseases . Journal of cellular biochemistry.