Sr Quality Associate Regulatory Supervisor- Fsp

2 semanas atrás

Lisboa, Portugal Fortrea Tempo inteiro

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Job Overview:

- Collaborate with peers across the organization in order to achieve client-centric delivery in a matrix organization. In particular, collaboration across all stakeholders within Site Readiness. Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.
- Summary of Responsibilities:
- Oversight and accountability for RA IRB/EC and Third Body submissions, including submission strategy, timeline planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems. Coordinate responses to queries and ensure the required timelines are met. Provides consolidated country requirements and regular status updates to project team and Client, as applicable. May be assigned to smaller projects in terms of size and complexity in regional and/or global role.-
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing, and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out.-
- Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC, and Third Body submissions. Evaluate the impact of clinical/regulatory changes on assigned project as well as overall business operations-
- Liaise with and/or support local teams to liaise with RA, IRB/EC, and Third Bodies on behalf of clients.-
- Review and input into required Start Up project plans. Distribute, implement, and monitor compliance to a Start Up project plan with respect to RA, IRB/EC, and Third Body submissions.- Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables.- Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope or overburn.- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects. Support audits (internal and external) and inspections, as needed. Support resolution of any findings.- Present/attend at external and internal meetings including, but not limited to: project core team and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick Off Meetings (KOM).- Contribute to the development of the group through participating in process improvement initiatives, e.g., developing and updating SOPs.- Mentor more junior Site Readiness team members. Perform any other duties as required by the department.- All other duties as needed or assigned.

Qualifications (Minimum Required):
- Recommended: Bachelor's Degree in Life Sciences or equivalent- Fortrea_ _may_ _consider_ _relevant_ _and_ _equivalent_ _experience_ _in_ _lieu_ _of_ _educational_ _requirements._

Language Skills Required:
- Speaking: Yes, English- Writing/Reading: Yes, EnglishCompetencies:
- Information purposes only:
- Focus on Customers, Innovate and Change, Work Well with Others, Develop Self and Teams, Gets it Done

Experience (Minimum Required):
- Minimum Required:
- Minimum 3 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic informatio

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