Marcela Novotna
Mysletín
Summary
Versatile Regulatory lead experienced in multitude clinical trials and indications. Excellent submission strategy planning and problem-solving abilities with a detail-oriented nature. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Ready to bring experience to a challenging new role.
Overview
7
7
years of professional experience
Work History
Regulatory Associate
EastHORN - A Novotech Company
2022.10 - Current
- Provide submission strategy to the client based on their specific needs
- Effectively communicated the requirements and documentation requests to actualize the proposed strategy
- Preparation of the Core submission package and performed QC on the content of all central submission packages
- Providing the Sponsor and internal Project Team information on regulations in European countries both inside EU/EEA and outside of EU/EEA
- Ensured local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards
- Interpreted regulatory rules or rule changes and ensures that they are communicated through company policies and procedures
- Provided training and support to CRAs in order to collect all necessarily documents for start up package, IP release as well as CTA and budget negotiations
- Successfully submitted and received authorization through CTIS for multiple trials, engaging various strategies to minimize timelines and ensure study approval
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
Clinical Project Administrator
EastHORN - A Novotech Company
2021.04 - 2022.10
- Provided clerical support to project team
- Set up and maintained clinical investigator and trial master files and documentation, performs quality checks of project files if required
- Prepared investigator budget payments and tracking systems; generated tracking reports as assigned
- Responsible for adaptation and finalization of country and site level documents, including ICF
- Acted as main contact with local Regulatory Authorities (RA) and Central/Regional Ethics Committees (EC)
- Prepared study-related documents and other materials for delivery to archives
- Became familiar with multitude of eTMF platforms
Controlled Substance Unit Coordinator and Veterina
Rutgers University And Medical School
2017.03 - 2020.03
- Organized University’s Controlled Substance (CS) program and Set in place standard operating procedures to minimize diversion of CS. Supported audits from DEA which the facility passed every year
- Oversight of large multi building animal research facility housing various rodent and USDA covered species with regards to health, handling and compliance with approved Institutional animal care and use committee (IACUC) protocols
- Assisted in the development and updating of policies related to the activities of the IACUC
- Developed and periodically updated the Post Approval Monitoring Program (PAM) to be instituted across all sites.
- Trained PIs and their staff on procedures as stated in their protocol and kept documentation of the training as well as timetable for retraining/training new personnel added to protocol
- Coordinated and facilitated USDA, DEA, OLAW, AAALAC and biannual IACUC facility inspections. Each of my facilities passed the visits without any major concerns
- Started a veterinary technician internship program in 2018 for Animal Science students interested in a career in research
Education
Bachelor of Science - University
Cornell University, College of Arts And Sciences
Ithaca, NY, USA05.2016
Skills
- Knowledge of country regulations and requirements
- Study protocols
- Research SOPs understanding
- Informed consent
- Good Clinical Practices
- Training & Development
- Multitasking abilities
- Teambuilding
- Organization and Time management
- Analytical skills
- Microsoft Office
- Planning and Coordination
Languages
Czech
Native language
English
Proficient
C2
Spanish
Elementary
A2
Affiliations
- Association of Clinical Research organizations of Czech Republic
Timeline
Regulatory Associate
EastHORN - A Novotech Company
2022.10 - Current
Clinical Project Administrator
EastHORN - A Novotech Company
2021.04 - 2022.10
Controlled Substance Unit Coordinator and Veterina
Rutgers University And Medical School
2017.03 - 2020.03
Bachelor of Science - University
Cornell University, College of Arts And Sciences
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