Experience

Trilogy Writing & Consulting

• Germany
• Writing and Editing
• 1 - 100 Employee

• • Jan 2023 - Present

  * Work in cross-functional teams to strategically author regulatory documentation required for the successful filing of marketing applications to regulatory bodies.* Write investigator brochures, clinical study protocols, clinical study reports, patient narratives, and clinical summary modules whilst adhering to ICH guidelines and FDA and EMA guidance.* Strong organization and communication skills, liaising with internal and external stakeholders to ensure consistent messaging and alignment between regulatory documents, while meeting aggressive timelines.* Lead kick-off meetings and comment resolution meetings to align messaging of regulatory documents and manage expectations across different functions (clinical, regulatory affairs, statistics, pharmacokinetics, pharmacodynamics, safety, and pharmacovigilance).* Create slide decks, agendas, and meeting minutes for kick-off meetings and comment resolution meetings.* Manage project timelines and budgets.* Coordinate quality control (QC) review, incorporation of QC comments and appropriate archival of QC documents.* Perform QC when necessary to supplement our internal QC Team's resourcing. Show less

• • Feb 2020 - Dec 2022



American Medical Writers Association (AMWA)

• United States
• Writing and Editing
• 1 - 100 Employee

• • Jun 2020 - Jul 2021

  As section editor for the Members Matters section of the AMWA journal my responsibilities included: * Managing and driving journal content.* Peer-reviewing articles submitted to the journal.* Seeking out and liaising with contributing authors that fit within the journal's scope.

• • Dec 2019 - Dec 2020

  * Maintained essential communications and correspondence with 100+ members of the local chapter.* Integrated new members into local chapter activities and events.* Wrote the minutes for every chapter leadership meeting. * Spearheaded the development and successful implementation of a quarterly newsletter initiative.



University of Miami Miller School of Medicine

• United States
• Higher Education
• 700 & Above Employee

• Doctoral Candidate (Therapeutic areas: pancreatic, lung, and prostate cancer)

  • Aug 2014 - Nov 2019

  Research Project: Exploiting redox-associated oncogenic stresses arising from tumor driving pathways. * Excellent project- and time- management skills, having coordinated the direction of 6 cancer research projects. * Strong leadership and mentoring skills, having supervised and mentored a total of 13 junior researchers. * A constructive, critical appraiser of the scientific literature, having acted as a peer reviewer for 3 biomedical science journals. * Excellent writing skills as evidenced by authoring 3 research manuscripts for publication, 5 standard operating procedures (SOPs), and 2 pre-clinical animal study protocols. * Successfully developed, optimized, implemented, and trouble-shot experimental protocols and procedures. * Strong administrative and budgeting skills, managing the budgets of 3 research grants amounting to a cumulative cost of $2,000,000. * An innovative, creative thinker, managing and designing the complex breeding strategies of 4 genetically engineered mouse models. Show less



University of Leicester

• United Kingdom
• Higher Education
• 700 & Above Employee

• Research Associate (Therapeutic area: lymphoma)

  • May 2013 - May 2014

  Research Project: Dissecting the function of the BCL7 family of proteins in the pathogenesis of leukaemias and lymphomas of mature B cells. Research Responsibilities and Key Findings: * Identified novel, previously unknown interacting partners of the SWI/SNF chromatin remodeling complex subunit BCL7A. * Developed breeding strategies for BCL7A and BCL7C genetically engineered mouse models. Research Project: Dissecting the function of the BCL7 family of proteins in the pathogenesis of leukaemias and lymphomas of mature B cells. Research Responsibilities and Key Findings: * Identified novel, previously unknown interacting partners of the SWI/SNF chromatin remodeling complex subunit BCL7A. * Developed breeding strategies for BCL7A and BCL7C genetically engineered mouse models.



University of Nottingham

• United Kingdom
• Research Services
• 700 & Above Employee

• Research Associate (Therapeutic area: ophthalmology)

  • Oct 2012 - May 2013

  Research Project: Hepatocyte growth factor in neovascular age related macular degeneration (AMD): In vitro study of its effects on human choroidal endothelial cells. Research Responsibilities and Achievements: * Compared the effects of different angiogenic growth factors on age-related macular degeneration disease progression. * Presented a poster of this work at the 17th Nottingham Eye Symposium and Research Meeting. Research Project: Hepatocyte growth factor in neovascular age related macular degeneration (AMD): In vitro study of its effects on human choroidal endothelial cells. Research Responsibilities and Achievements: * Compared the effects of different angiogenic growth factors on age-related macular degeneration disease progression. * Presented a poster of this work at the 17th Nottingham Eye Symposium and Research Meeting.



University of Nottingham

• United Kingdom
• Research Services
• 700 & Above Employee

• Master's Candidate (Therapeutic area: cancer immunology)

  • Jan 2012 - Jun 2012

  Research Project: IL-10 expression in pancreatic cancer. Project Results and Key Findings: Determined that high tumor cell IL-10 expression was an independent prognostic marker of worse survival in pancreatic cancer patients. Research Project: IL-10 expression in pancreatic cancer. Project Results and Key Findings: Determined that high tumor cell IL-10 expression was an independent prognostic marker of worse survival in pancreatic cancer patients.



University of Nottingham

• United Kingdom
• Research Services
• 700 & Above Employee

• • 2010 - 2011

  Research Responsibilities and Achievements: * Co-authored 2 research manuscripts published in peer-reviewed journals. * Developed analytical, research, troubleshooting and writing skills.* Taught new PhD students key laboratory techniques.

• • Sep 2009 - Jan 2010

  Research Project: Characterisation and immortalisation of human choroidal endothelial cells for research into age-related macular degeneration.