Adriana Voiculet
Bucharest
Summary
Efficient Technical Writer with 3 years of experience. Extensive understanding of technical research and updating records. Adept at distribution and adaptation to audiences. A results-oriented writing professional with experience preparing concise and accurate technical documents. Expert at delivering high-quality work within tight deadlines. Talented individual collaborates with cross-functional teams for accuracy and clarity of technical content.
Overview
8
8
years of professional experience
Work History
MEDICAL WRITER& REGULATORY AFFAIRS
Freelance
09.2021 - Current
- Compiling CTD dossier of API for the European market and also for the Commonwealth of Independent States (CIS)
- Compiling and updating Technical Files and Risk Management documentation for sterile, implantable class III medical devices at the current state-of-the-art
- Collaborating and communicating with the notified body in charge of the assessment of conformity
- Assessing, evaluating, and interpreting ASMF and other documents from suppliers to characterize the API
- Registrations in the Regulatory Tracking System
- Uploading documents in EDMS and completing the appropriate methods
- Providing regulatory information regarding the approved and marketed products
- Follow-up of the regulatory submissions and variations of the regulatory follow-up system according to the SOP / existing working instructions
- Execution of the processes necessary to comply with the regulatory information
- Reviewing scientific literature and industry reports to identify trends in research or best practices in treatment methods
- Writing reports that include details about a disease or treatment method, including possible side effects or risks of a treatment
- Preparing drafts of scientific papers based on research findings, which are then submitted to peer reviewers for revisions and publication
- Preparing drafts of clinical research protocols and study design plans for approval by institutional review boards (IRBs) before commencing research studies
- Researching and reviewing data about different medical conditions or treatments for pharmaceutical companies or other clients.
REGULATORY AFFAIRS ASSOCIATE
Rompharm Company
06.2020 - 09.2021
- Compiling CTD dossier of API for the European market and also for Commonwealth of Independent States (CIS)
- Compiling and updating Technical File and Risk Management documentation for sterile, implantable class III medical devices at the current state-of-the-art
- Collaborating and communicating with the notified body in charge of the assessment of conformity
- Assessing, evaluating, and interpreting ASMF and other documents from suppliers to characterize the API
- Maintaining contact with R&D, QC, QA, and purchasing department, to identify priorities and gathering data
- Responsible for compiling medical device regulatory submissions
- Respond to and resolve all regulatory related inquiries.
QUALITY®ULATORY SPECIALIST
SofMEDICA SRL
01.2020 - 06.2020
- Responsible for compiling medical device regulatory submissions
- Preparation of documents produced for participation in tenders
- Daily updating of the database with product documents
- Operating in accordance with the applicable procedures of the quality management system
- Preparation and management of notification documents for medical devices
- Periodic verification of the EC certificates for the commercialized medical devices
- Registration of product quality complaints
- Provides documentary support during corrective and withdrawal actions
- Respond to and resolve all related regulatory inquiries.
QA/QUALITY ASSURANCE SPECIALIST
Farmex Company SRL
08.2019 - 01.2020
- Perform quality assurance efforts on multiple application releases, and monitor and document testing activities
- Manage to test for application deployments and assign testing activities to the team
- Design, develop and maintain test cases and strategies for cross-browser testing and multiple user scenarios
- Satisfy release deliverables, project testing requirements, and other quality assurance responsibilities
- Collaborate with the team to understand product changes and QA testing requirements to deal with issues/defects in a timely manner
- Establish a testing feedback loop with other developers and team members
- Create written documentation and procedures for application testing and compliance
- Debug test environment, automate sprints and develop testing scenarios.
REGULATORY AND MEDICAL WRITER
CELLVIE GmbH
09.2018 - 06.2019
- Registrations in the Regulatory Tracking System
- Uploading documents in EDMS and completing the appropriate methods
- Providing regulatory information regarding the approved and marketed products
- Follow-up of the regulatory submissions and variations of the regulatory follow-up system according to the SOP / existing working instructions
- Execution of the processes necessary to comply with the regulatory information.
PHARMACOVIGILANCE AND SCIENTIFIC OFFICER
MLD-V Trading
01.2017 - 07.2018
- Collection, documentation and evaluation of reports of drug risks according to legal requirements
- Updating documents in accordance with national and European legislation
- Step-by-step representative / QPPV for Romania
- Preparation of documents for audits and standard dossiers
- Training of medical representatives
- Manage literature data and reference databases
- Participation in the preparation and updating.
JUNIOR RESEARCHER
National Institute for Chemical-Pharmaceutical Research and Development
03.2016 - 01.2017
- Development of new method for the administration of anticancer drugs
- Technical and scientific documentation
- Conferences and meetings with interdisciplinary teams from national and international research.
Education
DRUG REGULATORY AFFAIRS (DRA) -
Udemy
Online02.2023
MEDICAL WRITING FOR HEALTHCARE PROFESSIONALS -
Udemy
Online01.2023
CLINICAL RESEARCH ASSOCIATE (CRA) TRAINING FOR ADVANCED LEVEL -
Avantyo Institute of Clinical Research
Online04.2022
GOOD PHARMACOVIGILANCE PRACTICE PERSON IN CHARGE OF PHARMACOVIGILANCE -
COTIMED COMPANY
Online02.2022
Ph.D. -
University Politehnica of Bucharest, Faculty of Chemistry And Applied Sciences
Bucharest, Romania 01.2015
Master of Science -
University Politehnica of Bucharest, Faculty of Me
Bucarest, Romania01.2008
Bachelor of Engineering -
University Politehnica of Bucharest, Faculty of Ch
Bucharest, Romania01.2006
Skills
- Research
- Microsoft Office
- Medical Devices
- Writing
- Registration
- Revisions
- ICH & GCP
- Scientific Literature
- Risk Management
- Chemistry
- Quality Management
Languages
Romanian
Native language
English
Intermediate
B1
German
Elementary
A2
Personal Information
- Title: MEDICAL WRITER & REGULATORY AFFAIRS
- Driving License: Driving license category B
Publications
- FABRICATION AND TOXICITY CHARACTERIZATION OF A HYBRID MATERIAL BASED ON OXIDIZED AND AMINATED MWCNT LOADED WITH CARBOPLATIN, Central European Journal of Chemistry, 08/2014
- FABRICATION AND TOXICITY CHARACTERIZATION OF A HYBRID MATERIAL BASED ON OXIDIZED AND AMINATED MWCNT LOADED WITH CARBOPLATIN, Toxicology in Vitro, 08/2016
Timeline
MEDICAL WRITER& REGULATORY AFFAIRS
Freelance
09.2021 - Current
REGULATORY AFFAIRS ASSOCIATE
Rompharm Company
06.2020 - 09.2021
QUALITY®ULATORY SPECIALIST
SofMEDICA SRL
01.2020 - 06.2020
QA/QUALITY ASSURANCE SPECIALIST
Farmex Company SRL
08.2019 - 01.2020
REGULATORY AND MEDICAL WRITER
CELLVIE GmbH
09.2018 - 06.2019
PHARMACOVIGILANCE AND SCIENTIFIC OFFICER
MLD-V Trading
01.2017 - 07.2018
JUNIOR RESEARCHER
National Institute for Chemical-Pharmaceutical Research and Development
03.2016 - 01.2017
DRUG REGULATORY AFFAIRS (DRA) -
Udemy
MEDICAL WRITING FOR HEALTHCARE PROFESSIONALS -
Udemy
CLINICAL RESEARCH ASSOCIATE (CRA) TRAINING FOR ADVANCED LEVEL -
Avantyo Institute of Clinical Research
GOOD PHARMACOVIGILANCE PRACTICE PERSON IN CHARGE OF PHARMACOVIGILANCE -
COTIMED COMPANY
Ph.D. -
University Politehnica of Bucharest, Faculty of Chemistry And Applied Sciences
Master of Science -
University Politehnica of Bucharest, Faculty of Me
Bachelor of Engineering -
University Politehnica of Bucharest, Faculty of Ch
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