Senior Study Start Up Associate
Location
Brasil | Brazil
Job description
The Sr. Study Start Up Associate fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for preparing, submitting and following up on initial and amended Regulatory Agency (RA), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval.
What you will be doing:
- Manages activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries
- Manages central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the associate is responsible for
- Ensures that IP labels are in adherence to country requirements and submitted where applicable
- Manages the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA
- and Central IEC as appropriate
- Tracks and reports central submission/approval progress in Boehringer´s applicable systems
- Performs role of local reviewer in the QC process as appropriate
- Provides consultancy to the client on any country-specific issues if requested by the study start- up or clinical teams
- Attends project team meetings as determined by the start-up or clinical teams
- If applicable for the country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation
- Contributes to the maintenance and collection of regulatory intelligence by ensuring that relevant tools and systems are up to date; communicates new information or changes to the regulatory team
- May work with regulatory team members to provide regulatory consulting services
- Maintenance of the accurate, up to date country knowledge repository
- Serve as country consultant for the regulatory team
- Provides mentoring and training for lower level resources
- Supports lower level resources with more complex submissions requirements
- May liaise with team/other department members to validate country intelligence before liaising with the appropriate regulatory team members to ensure that the information is disseminated appropriately
You are:
- Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
- Prior experience preparing ANVISA DDCM submissions
- Expert knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations
- Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required
- Read, write, and speak English; fluent in host country language
Visit our careers website to read more about the benefits of working at ICON:
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. #J-18808-Ljbffr
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