Jobs Available at ICON plc

Responsibilities and Qualifications:

Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:

• Manage Quality Issues.
• Lead Quality Issue Investigations.
• Supports Operations in Root Cause Analysis and CAPA Plan preparation.
• Support Effectiveness Check development and outcomes.
• Manage CAPAs resulting from Sponsor Audits, Inspections and/ or Internal Audits.
• Assist with the implementation and maintenance of an effective Quality Management System/Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
• Support business development activities and Q&C initiatives as needed.
• Read, write and speak fluent English.

What you will have:

• 6+ years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry.
• Advanced knowledge of GCP (Good Clinical Practice).
• Excellent organizational skills.
• Knowledge of internal auditing standards.
• Must possess a technical knowledge that is applicable to clinical drug development.
• An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
• Experience in investigator site, vendor, and process audits.
• Open to occasional travel, if required
• Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
• Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
• Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
• Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision

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What you will be doing:

• Developing and implementing quality assurance strategies and processes to support clinical trial activities.
• Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborating with project teams to identify and address quality issues and implement corrective actions as needed.
• Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices.
• Contributing to the development and maintenance of quality management systems and documentation.

Your profile:

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry.
• Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
• Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

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• As a Statistical Programmer II you will be responsible for statistical aspects of clinical and preclinical research projects. Project responsibilities include study design, case report form development, analysis planning and scheduling, analysis and interpretation of data, and reporting of results. May be required to coordinate analysis efforts across multiple research projects conducted for a client.

You will have strong demonstrable experience in:

• Designing, developing, validating and documenting SAS programs to generate analysis datasets, generate summary tables, figures and listings.
• Support statisticians in the development and review of Statistical Analysis plans and programming specifications
• Responsible for assisting data management with implementing protocols and CRFs

We are looking for:

• Bachelors or Master's degree in statistics, biostatistics, or related field
• SAS Programming experience – (ideally 3 yrs or more)
• Major experience in the Pharmaceutical/CRO industry

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What you will be doing

• Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
• Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
• Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
• Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
• Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.

Your profile

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of global regulatory requirements and guidelines.
• Proven track record of successful regulatory submissions and approvals.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
• Proven leadership experience