ANTHONY PEREZ
Newington,CT
Summary
Quinnipiac University Two-year Clinical Internships rotating in Med-Surg, Pediatric, ICU, and Adult/Pediatric Psychiatry Patient head to toe physical assessment, bedside monitoring, medication administration, Basic Life Support (BLC) Certification 2019, patient charting, prioritization and organization, team leadership. Medical Writer for pharmaceutical and medical device industry Skilled in writing protocols clinical study reports, amendments, Investigator Brochures, Clinical Summary Experiences, ISS & ISE, SOPs Expertise in providing on time high quality report assignments Detail-oriented, able to manage others and work independently Co-authored several publications in The Journal of Clinical Microbiology Medical laboratory professional skilled at precise documentation, isolating bacteria and processing and handling clinical specimens. Excellent diagnostic microscopy skills with gram-staining of cerebral spinal fluid, positive blood cultures, tissue, and other biological specimens.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Medical Writer
EMD Serono
Rockland, MA
09.2013 - 01.2014
- Provided quality project management with internal team members, CROs, and key decision makers in clinical programs for oncology, systemic lupus erythematosus, and, osteoarthritis
- Coordinated the preparation of investigator's brochures, protocols, clinical trial reports, International Medicinal Product Development (IMPD) Common Technical Document Module 2
- Successfully prepared strategic submission documents: (e.g
- INDs, briefing books, ISS, ISE, and, clinical summaries)
Medical Writer
Boston Scientific Corporation
Marlborough, MA
05.2008 - 08.2012
- Achieved on-time preparation of medical device project-driven documents that support the regulatory writing needs of the BSC Preclinical Sciences department
- Successfully completed synopses, protocols, preclinical study reports, device analytical reports, departmental standard operating procedures (SOPs)
- Successful development of QC, and, publication strategy of preclinical and clinical manuscripts
- Worked successfully with members of preclinical, clinical, regulatory, R&D, and, project managers to develop and manage timelines for timely and successful submission of regulatory documents to the FDA
- Successfully created documents for regulatory submissions in support of investigational device exemption-(IDEs) for the common technical document (CTD)
Manager of Medical Writing
Epix Pharmaceuticals
Bedford, MA
11.2007 - 04.2008
- Management of writing projects in Regulatory Affairs & Quality
- Worked on QA of data, appendices and references for all projects e.g
- Clinical research reports, clinical study reports (CSRs), investigator's brochures (IBs) and annual reports
- Managed and ensured quality and consistency or multiple writing projects performed by external contractors and clinical research organizations (CROs)
- Therapeutic Areas: neurocognitive & oncology.
Medical Writer
Millennium Pharmaceuticals
Southborough, MA
09.2007 - 11.2007
- QA reviewed and edited of Velcade's promotional and manufacturer's package insert
- Worked successfully with Millennium Managers to develop and manage timelines for timely and successful submission of Velcade's package insert
- Therapeutic Area: oncology
Medical Writer
Averion
Southborough, MA
04.2005 - 10.2007
- Wrote and prepared clinical protocols, clinical study reports (CSRs), brochures and common technical documents (CTDs) write and revise internal standard operating procedures (SOPs) and pharmacovigilance (PVG) safety protocols and write PVG safety narratives
- At the CEO's request, research and write high quality pre-clinical and clinical summary of safety (ISS) reports for medical devices, pharmacological drugs, diverse therapeutic/disease indications and lumbar pain measurement scales for submission to the Food and Drug Administration (FDA).
Microbiology Technologist
Brigham & Women’s Hospital
Southborough, MA
06.2003 - 12.2004
- Wrote and revised clinical microbiology media and test protocols, microbial identification via light microscopy interpretation of Gram-stain, Giemsa and India Ink smears including regular and “stat” smears of cerebral spinal fluid, blood and tissue, work-up of positive blood cultures and computer accession and labeling/planting of clinical laboratory specimens
Education
Bachelor of Science of Nursing Registered Nurse (BSN-RN) -
Quinnipiac University
01.2022
Bachelor of Arts: Sociology & Health Law -
Brandeis University
01.1998
Skills
- Bilingual fluent in Spanish
- Complex problem solver
- Excellent Clinical Researcher via PubMed, Cochran, FDA database
- Proficient in MS Word, MS Excel, MS PowerPoint
- Excellent project management skills
- Manual Writing
- Content Editing
- External Team Collaboration
- Editing
- User Documentation Production
- Publication Development
- Microsoft Office
- Decision-Making
- Remote Office Availability
- PPE Use
- Emergency Procedures
- Patient Discharging
- Bi-Lingual in English and Spanish
- Taking Vitals
- Acute and Rehabilitative Care
- Treatment Planning
- Medical Laboratory Procedures
- Strong Clinical Judgment
- Indirect Patient Care
- Clinical Information System Management
- Medical Evaluation
- Patient Education and Counseling
- Sanitation
- Strong Medical Ethic
- Feeding Assistance
- Direct Patient Care
- Postpartum Care
- IV Drug Therapy Management
- Evaluations
- Body Mechanics Knowledge
- Care Plan Development
- Licensed RN
- Direct and Indirect Patient Care
- Inpatient and Outpatient Care
- Physical Assessments
- Documenting Vitals
- Collecting Vitals
- Medication Distribution
- Intake and Discharge
- Managing Deadlines
- Seizure Management
- Medication and IV Administration
- Complex Problem-Solving
- IV and Venipuncture Certified
- Patient Monitoring
- Professional Bedside Manner
- Emotional Awareness
- Patient Evaluation
- Vascular Care Understanding
- Patient and Family Advocacy
- Patient Assessments
- Disease Management Programs
- Diabetes Management
- Patient Management
- Chronic Disease Management
- Infectious Disease Control
- Health Care Consultation
- Mobility Assistance
- Chart Updating
- Care Planning
- Emergency Response
- Medical Assessment
- Wound Care
- Culturally-Sensitive Care
- ADL Assistance
- Data Collection
Certification
- Medical Writing Certificate, trained in GCP, GLP, GDP, FDA & EMA regulations.
- Medical Laboratory Technologist trained and certified internally.
- BSN-RN, Connecticut, 213594
- Phlebotomist, 2866224
Languages
Spanish
Professional
Timeline
Medical Writer
EMD Serono
09.2013 - 01.2014
Medical Writer
Boston Scientific Corporation
05.2008 - 08.2012
Manager of Medical Writing
Epix Pharmaceuticals
11.2007 - 04.2008
Medical Writer
Millennium Pharmaceuticals
09.2007 - 11.2007
Medical Writer
Averion
04.2005 - 10.2007
Microbiology Technologist
Brigham & Women’s Hospital
06.2003 - 12.2004
Bachelor of Science of Nursing Registered Nurse (BSN-RN) -
Quinnipiac University
Bachelor of Arts: Sociology & Health Law -
Brandeis University