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Sr Writer

Atlanta, Georgia, United States
October 18, 2016

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Davi Sal. - - +770-***-****

Summary: Involve globally in direct personnel management assistance and maintain an overview of the writing activities for many aspects of Health care. Effective technical communication with clients (Vendors, Investigators /Coordinators, Business, Health professionals) to ensure the style maintenance, version control tracking, and processing of regulatory documents in preparation for filing. Work closely with Senior Project Managers especially in regards to produce technical, medical writing for SOPs, the governance of Sites Initiation to Business close out. Oversee the translations of materials in English, Spanish, French for submissions and publications of documents to Central Institutional Review Boards (IRB/EC) and the completion of routine file reviews to ensure inspection readiness, GBP, GCP, GMP, GLP and SOP compliance. Perform “gap analysis” and have strong knowledge of validation of IT systems, data privacy, as well as review of business transactions for payments to clients. Provide excellent customer service to stakeholders (Sponsors, Investors, Recipients, and Donors).

Other experience includes: Documents Management, Clinical monitoring (CRA), QA, QC, Senior Archivist for Global Clinical Trials companies (studies in multiple languages – English, French, and Spanish) and therapeutic areas, Neurology (with indication on Alzheimer), Cardiac, Respiratory, and Oncology.

Software: CTMS- INFORM- CI-INFORMANT- DTS – INNTRAX – CRF Navigator (scanning) – Social Media -Word Press - Photoshop.

BackupSkills Enterprise – Kennesaw, GA 2013- present

Field Monitoring - Technical Writer

Technical quality writing skills, as well as excellent verbal communications skills.

Strong QC review, editing, proof-reading, and publishing experience working with print and web communications materials. – French – English – Spanish.

Experience in the areas of SOPs, ICF, Client’s letters, Submissions to regulatory.

Assist with Gap analysis, Publishing, QC 4/C magazines, including public relations, internal and external communications, advertising coordination, and media relations.

Internet technologies, such as social media networks and blogs.

Contribute to social media posts, blogs, articles, press releases, case-studies.

QUINTILES LABORATORY Inc., Smyrna, GA 2011 - 2014

Monitoring of clinical trials - direct personnel management assistance.

Maintained an overview of the active clinical trials and their assigned CRAs.

Assisted in developing, planning, monitoring and evaluation of manpower.

Ensured that CRAs are appropriately trained and performed their assigned activities in compliance with standard operating procedures.

In liaison with the Senior Project Managers - allocated appropriately skilled and experienced CRAs to projects. – CELL: 1+770-***-****

Assisted Clinical Team (CTL) and Clinical Research Associates (CRAs) juniors with accurately updating and maintaining clinical systems.

Ensured all batches of IMP manufactured are QC for compliance with the Product.

Communicate with the Clinical Managers and their clinical teams to schedule quarterly investigator payments. (and tracking of miss-payments)

Good understanding of all aspects of US and EU regulatory processes.

Perform Submissions to Canada IRBs, US central IRBs, and EU documents.

Assist with translation of documents for IRB submission.

Assist STLs with preparation, handling and distribution of Clinical Trial Supplies.

Follow up with tracking and management of Case Report Forms (CRFs), queries resolution, and clinical data flow.

Act as a central contact for the clinical team for designated project communications in French, Spanish correspondence and associated documentation.

Proposal Developer - Quintiles, Inc. 2010

Reviewed Requests For Proposal (RFP). Identified information for proposal text and budget development and worked closely with proposal development team to prepare and finalize proposals.

Prepared text and budget for proposals, rebids and related documents.

Participated in strategy calls to discuss customer requirements and identified discrepancies.

Performed quality control edits on all documents and participated in the finalization of documents and distribution to the customer and internal departments.

Updated and maintained corporate databases as required and ensured accurate information is included in tracking reports.

Coordinated Global shipments of Lab results between countries.

Prepared and distributed status, tracking and project finance reports. Prepared timely Reports for Outsourcing/ Budget Dept. resulting in Project Awards.

Managed Laboratory Events Schedule for different group of Patients

(Oncology, CNS, Cardiology- Urology, Allergy, infectious disease etc…).

Created Global Lab Events Schedule Spreadsheet using Excel Data Base (per Protocol.

Communicated with Budget managers about multiple studies and Lab tests taking place simultaneously in different countries.


CRA-Sr. ARCHIVIST- - (Promotion) 2005 – 2009

Studies review, and ensured completeness for FDA Inspections.

Sites Monitoring, and Conducted internal audits – Mock FDA audits.

Verify US/EU GMP with Contract vendors for batch release and QC certification.

Managed documents for 35 live clinical trials studies with accuracy.

Acted as Quality Control agent during Site Selection, Monitoring visits. – CELL: 1+770-***-****

Saved the company money by maintaining global communication with Europe/

Canada and Mexico in French and Spanish. (included E-mails translation).

Developed coding system for clinical trial documents classification.

Input to Standard Operating Procedures (SOP) – to CRF design.

Quality Control Associate 2000 – 2005

Assisted with Development of Project Management Plan and Sites Qualification.

Assisted with clearance of Sites selection, initiation, monitoring, and close-out.

Conducted all clinical site activities according to the Monitoring Plan.

Adept at managing multiple projects, filing of clinical trial Protocols, Informed consent, IRB, Monitoring Report, Case Report Form, Clinical Study Report, etc...

Trained and provided computer access level to CRCs – CRAs – CPMs.


Bachelor of Science in Health Care Services (BSHCS), University of Phoenix,

Dunwoody Campus, GA

A.S., Accounting - MAURICE LAROCHE Accounting School.

Nursing background, Essex County, N.J.

SKILLS: Systems Used for Clinical Trials Studies

Computer Literacy: Microsoft Outlook, MS Word, Adobe, Access Excel I-II – PowerPoint -INFORM-DTS–INNTRAX – INTRALINKS –IVRS –CAPAs -Oracle Clinical –Visual Source -EDMS – CTMS – IMPACT - CRF Navigator (Scanning)–Clinical Informatics (CI)--e-CTS--SAFRANS System Informant CONNEXUS IRB-Services – Share point.


Technical Writing, Editing, Business Communication –

Barnett Professional Services (GCP training –2014)

Good Clinical Practice: ICH - QP GCP- cGMP- GLP- GTP Regulations.

Kriger International – Certificate: CRA – ICH/GCP - CPM

Quality Assurance - Quality Control - IT security: Security awareness (en)

Standard Operating Procedures: Clinical Study SAE Summary Reporting

Clinical Trial authorization (CTA) training. - HIPAA

Clinical Research Associate Training (Barnett program).

Fluency in reading, writing, speaking English -French- Spanish.

Read and basic in German, Italian, and Dutch.

Publication:“Backup Skills for a Tough Job Market”–Davi

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