Regulatory Affairs Specialist

hace 3 días

Bogotá, Bogotá D.E., Colombia 535 ICR Colombia - COL A tiempo completo
Project Manager - Language Services

We are seeking a highly skilled Regulatory Affairs Specialist to join our Language Services team at ICON, a world-leading healthcare intelligence and clinical research organization.

Salary: $80,000 - $120,000 per year, depending on experience.

Job Description:

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the expansion of our business growth within the Language Services team through Regulatory Labelling authorization services. Your expertise in this complex process is essential to train our Project Management and Client Services departments, ensuring they can handle these projects.

You will lead the setup of training programs and expedite our service offerings, enabling us to strategically enhance our portfolio.

Key Responsibilities:

  • Lead the training plans for Regulatory Affairs within the Language Services department.
  • Develop successful working relationships with clients (internal and external), ensuring repeat business return to ICON.
  • Responsible for project scheduling and implementation, resource requirements, and deliverables.
  • Develop and maintain project management plans.
  • Responsible for developing workflows for Regulatory Affairs language services within the organization.
  • Responsible for risk mitigation strategies, associated action plan, and issue resolution.
  • Manage cross-functional project teams.
  • Provide direction and support to project teams.
  • Manage projects in accordance with the contract budget and contracts.
  • Collaborate with Client Services to ensure successful completion of change orders.
  • Manage relevant invoicing procedures and revenue recognition, as needed.
  • Track project deliverables using appropriate tools.
  • Effectively monitor and report on the progress of the project to all stakeholders.
  • Implement QC activities as necessary and monitor relevant quality metrics.
  • Develop a succession plan and ensure an effective hand-over in the event of a team change.
  • Organize and monitor workloads of the department or functional team.

Requirements:

  • Educated to a degree level preferable within foreign languages, linguistics, translation, and/or interpretation.
  • +6 years prior applicable experience.
  • Experienced with localization project management or translation project management roles for LSP.
  • CAT tools, TMS, and word formatting experience required.
  • Strong Regulatory Affairs Labelling experience.
  • Strong attention to detail and well organized with an ability to manage multiple complex projects.
  • Adaptable and able to problem solve effectively.
  • Strong communicator with an ability to present to various audiences.

Benefits:

  • Competitive salary range: $80,000 - $120,000 per year.
  • Annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

About Us:

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates.

Interested in the role? 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.

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