Parexel

Research Analyst

• Act as Parexel’s direct contact with assigned sites
• Build relationships with investigators and site staff
• Facilitate and support site with access to relevant study systems
• Perform on-site visits and remote visits
• Ensure timely and accurate completion of project goals

Clinical Research Associate – Japanese/Korean or Japanese/Taiwanese Speaker

Clinical Operations

• Odpowiada za budżety kraju i ośrodka, w tym - Opracowywanie, negocjowanie i finalizowanie umów dotyczących badań klinicznych (CTRA).
• Nadzór i śledzenie płatności związanych z badaniami klinicznymi.
• Uzgadnianie płatności po zakończeniu badania.
• Nadzór nad ustawą o zagranicznych praktykach korupcyjnych (FCPA), kontrolą podmiotów wykluczonych...
• Wpływanie na śledczych, partnerów zewnętrznych i operacje krajowe w celu przestrzegania celów budżetowych i uzgodnionych terminów płatności.

Clinical Operations Manager – Finance

Compliance

• Support Global and/or local Regulatory teams
• Prepare and coordinate documentation to meet national submission requirements
• Maintain regulatory compliance and support HA inspections
• Serve as main client contact and ensure project quality and timeliness

Senior Regulatory Affairs Associate – Regulatory Affairs Generalist

• Previous experience working in industry in support of Global Labeling, Regulatory (Clinical / Safety), or Medical Writing for labelling updates
• Use of document management tools (internal systems) and external platforms
• Strong familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
• Knowledge of the triggers that lead to a CCDS update, and ability to manage/coordinate impact assessments for technical changes impacting labelling
• Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling
• Familiarity with CCDS governance processes in Pharma Companies
• Some understanding of Periodic Safety Update Reports (PSUR) and potential impact on labelling
• Appreciation of the relationship between labelling and artwork processes
• Understanding of the regulatory processes required to update labelling of a product e.g different variation categories
• Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labelling variation.
• Some appreciation of the Regulatory requirements for labelling updates in different regions e.g. EU, EAEU, US and APAC.
• Knowledge of local labelling requirements.
• Review and approve promotion and advertising materials, medical education, and social media content in accordance with approved labelling and clinical materials. Participate in the promotion review committee and provide regulatory guidance in accordance with local market requirements.

Regulatory Affairs Consultant – Labelling

• Develops import/export strategies for projects in collaboration with cross functional teams.
• Prepares actionable plans and ensures all stakeholders are informed.
• Serves as a subject matter expert for all trade activities and compliance.
• Evaluate project objectives, products and countries involved for import/export strategies.
• Create and maintain comprehensive project documentation.
• Verify project contracts and ensure compliance with laws and regulations in each region.

Global Trade Compliance Leader

• Oversees end-to-end labeling development and implementation for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets.
• Ensure compliance with country-specific regulatory requirements.
• Manage operational processes for artwork creation, translation, and implementation.
• Act as key partner to GRA Regions, Regulatory CMC, and supply chain.

Clinical Research Associate – Japanese/Korean or Japanese/Taiwanese Speaker

Clinical Operations Manager – Finance

Senior Regulatory Affairs Associate – Regulatory Affairs Generalist

Regulatory Affairs Consultant – Labelling

Global Trade Compliance Leader

Senior Regulatory Affairs Consultant