Our Team

Experienced Senior Medical Writer/Scientific Writer with a strong understanding of clinical research processes
and international regulatory requirements. Proven ability to document and report clinical study procedures and
results. A reliable team member with excellent work ethic, blending medical writing expertise and analytical
skills. Proficient in creating, editing, and coordinating the production of clinical and scientific documents.
Accomplished in developing various clinical regulatory documents and medical communications projects for
global pharmaceutical clients and non-profit organizations.
Independent writer 8 years expertise in regulatory documents for phase 1 to phase 4 clinical studies
(including protocol, CSR, CTD module 2).

• Prepared and review CTD modules (2.4, 2.5, 2.6, 2.7).

• Expertise NIH grants, manuscripts.

• Coordinate, write, and compile clinical study reports (CSRs).

• Provide support on medical writing templates, SOPs and document-related processes.

• Integrated scientific expertise with regulatory knowledge for standard responses submitted for approval.

• Proficient in computerized information systems and databases.

• Proficiency with the following technology: Microsoft Word, Microsoft Office, SharePoint, Adobe

  Acrobat, StartingPoint Templates and associated Author Toolbar, EndNote, PerfectIT, Veeva.

• Collaborated with cross-functional team members (clinical operations, clinical development, regulatory) to ensure related documents such as statistical analysis plans and tables, figures, and listings, and studyspecific documentation are accurate and provide all required data for a CSR.

• Demonstrated understanding of content expectations for eCTD summary and overview documents applicable to INDs as well as US and EU marketing applications.

• Knowledgeable in internal and external research regulations, GCP guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance, research budgets, etc.