Jacqueline Pecimon
Bratislava
Summary
Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.
Overview
24
24
years of professional experience
Work History
Site Activation Manager
Syneos Health
Bratislava, Slovakia
02.2022 - 06.2024
- Performs assigned activities within the SSU Project Delivery Team for projects during start-up and throughout the life cycle
- Responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a country, region or globally, within the assigned projects
- Responsible for preparation of core submission packages for sponsor's review and approvals; for preparation of Master Informed Consent forms
- Oversees and drives Site Contracts negotiations and executions
- Develops SSU timelines as required and provides the reports progress including plans to address potential risks / gaps to the project team
- Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed
- Interacts with sponsors directly, participates at sponsor’s meetings
Regulatory Lead
Syneos Health
Bratislava, Slovakia
10.2021 - 01.2022
- Responsible for coordinating and managing the SSU team during the study maintenance phase
- Responsible for review and assessing of clinical trial regulatory documents
- Responsible for planning and management of scope, timeline, and resources
- Acting as a main point of contact for the customers
- Collaborates with all major functional area leads including (SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing)
- Responsible for development and maintenance of relationships with customers in alignment with their assigned projects
- Participation in launch meetings, review meetings and project team meetings
- Not only limited to regulatory part of the study phase, but also acting a Site Contract Lead for the assigned studies
Regulatory Start-Up Specialist I
Syneos Health
Bratislava, Slovakia
08.2021 - 09.2021
- Responsible for overseeing of all project SSU activities, responsible for Life cycle maintenance amendment activities timelines, communication and coordination with country start-up specialists for all RA, IEC/IRB submission deliverables
- Communication and coordination with Site Contract Negotiator(s) for amendments to contracts and/or budget independent to the submission deliverables
Regulatory Start-Up Specialist I
IQVIA
Bratislava, Slovakia
01.2020 - 07.2021
- Regulatory and Start‑up Specialist in EMEA FSP Team, handling mostly EMEA region (the Netherlands, Italy, Slovakia) as well as UK and South Africa
- Exposure to submissions to Regulatory Authorities and Ethics Committees, contract and budget negotiations and Country level Informed Consent Forms
Senior Regulatory Affairs Specialist
FONA Dental s.r.o.
Bratislava, Slovakia
04.2012 - 04.2019
- Responsible for registration of dental medical devices worldwide covering initial communication with Sales Managers / Head of Sales Managers, distributors or outsourcing registration agencies from various countries regarding individual requests for registrations of specific dental products
- Determining of pre-submission strategies, clarification of needs for registration documentation requested for applications across the countries with all foreign manufacturing sites in Germany, Italy, Denmark, US and China
- Preparation and completion of registration dossiers based on individual country’s requests in compliance with their legal requirements for registration applications, standard certificates required for registration (ISO, CE Certificates, Declarations of Conformity etc.), follow up and ensuring of renewals of registration approvals
- Submissions within given timelines; preparation of data for annual budget related to availability of specific products on the markets depending on obtaining of registration approvals
Regulatory Affairs Specialist and Administrative Assistant
Alcon Pharmaceuticals Ltd.
Bratislava, Slovakia
04.2000 - 03.2012
- Regulatory affairs ensures fulfillment of country regulatory commitments, in addition to supporting the regulatory submission activities
- Represents the regulatory department and actively participates at cross functional teams
- Acts as a subject matter expert and provides valid regulatory guidance to support ongoing regulatory activities in the country of responsibility
- Responsible for communication with headquarters regarding completion and submission of drugs registration dossiers, renewals, variations to local authorities in Slovak Republic – ŠUKL
- Submits medical devices certificates and registration documents to local authorities requested for notification of MD’s and active communications with local authorities
- Monitors Slovak / EU legislation related to RA issues reimbursements / categorization – responsible for submission of applications for prices, price proposals to MoH (MZ SR), tracking the local legislation related to categorization, price referencing
- Pharmacovigilance / post-marketing surveillance within the territory of Slovak Republic – follow up of company’s internal SOP related to pharmacovigilance; collects and reports the adverse events (drugs) and adverse incidents (medical devices) + follow-ups; submits PSURs (Periodic Safety Updated Reports)
- Administrative part of work leads general administrative agenda of the company on daily basis; financial reporting
Education
High School Diploma -
Secondary Economic School
Bratislava, Slovak Republic06-1989
Skills
- Team leadership
- Time management
- Decision-making
- Verbal and written communication
- Complex Problem-solving
- Staff training and development
- Task delegation
- Relationship building
- Strategic planning
- Cross-functional teamwork
Timeline
Site Activation Manager
Syneos Health
02.2022 - 06.2024
Regulatory Lead
Syneos Health
10.2021 - 01.2022
Regulatory Start-Up Specialist I
Syneos Health
08.2021 - 09.2021
Regulatory Start-Up Specialist I
IQVIA
01.2020 - 07.2021
Senior Regulatory Affairs Specialist
FONA Dental s.r.o.
04.2012 - 04.2019
Regulatory Affairs Specialist and Administrative Assistant
Alcon Pharmaceuticals Ltd.
04.2000 - 03.2012
High School Diploma -
Secondary Economic School