Manager, Scientific Affairs
2 months ago
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The role manages, oversees and leads Test Validations, i mplementing new assays across 4 clinical laborat o r i es globally. This role will support m ultiple platforms and departments including Clinical Chemistry, Hematology, Special Chemistry, Immunology, Pathology, Molecular Biology, and Molecular Diagnostics. The applicant is not required to be an subject matter expert in all these disciplines but should be knowledgeable enough to communicate across disciplines. This role a pproves performance of analytical validations within ICON Laboratory Services including the review of assay product inserts, preparation of validation plans, identification and attainment of suitable samples for validation studies, the performance of validation experiments, analysis and quality control of data and the preparation of validation reports.
This pivotal role involves ensuring that all diagnostic tests and procedures meet the highest standards of accuracy, reliability, and compliance. The ideal candidate will have e xtensive experience in clinical laboratory testing, a strong background in quality assurance, and proven leadership abilities. This role is office based (hybrid working) at our global HR in Dublin 18.
Key Responsibilities:
Lead and manage the validation and verification of diagnostic tests, including new assays and instruments
Design, perform, and analyse Accuracy, P recision, Reference Range, AMR and other standard validation / verification experiment s
Manage the validation of complex and Lab Developed tests including modifi cations to existing tests .
Work directly with Sponsors on Sponsor - specific validations and requirements
Ensure that all validation processes comply with regulatory requirements, industry standards, and internal quality guidelines while following and maintaining Global SOPs .
Conduct regular assessments of validation practices to identify areas for improvement.
Perform root cause analysis on quality issues and suggest corrective and preventive actions.
Supervise and mentor a team of Global V alidation Analysts
Provide training and support to team members on validation techniques and best practices.
Foster a collaborative and high-performance work environment.
Identify and implement training programs as necessary to ensure they receive training in supervisory skill development
Productively work with internal groups such as Regulatory Affairs, Medical Affairs, Clinical Research, Project Management, and/or Quality Assurance to ensure efficient operations across the organization
Work closely with cross-functional teams including Laboratory operations, Global Q uality C ontrol, and R egulatory A ffairs.
Liaise with global laboratories to coordinate validation activities and share best practices.
Keep management informed of project status in relation to quality and timelines using the validations tracker .
Independently provides additional medical communications writing and editing services as required (for example for manuscripts, abstracts and scientific posters).
Stay current with changes in regulatory requirements and ensure that validation processes are updated accordingly.
Prepare and present documentation for regulatory submissions and inspections in collaboration with Regulatory Affairs .
Maintain accurate and thorough documentation of all validation activities.
Prepare comprehensive reports for internal stakeholders and regulatory bodies.
Exhibit excellent written and oral communication and presentation skills. Is able to collaborate well at a complex level.
What you need:
- Education: Bachelor’s degree in Clinical Laboratory Science , Biomedical Science, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in clinical laboratory testing, with at least 3 years in a management or leadership role focused on test validations.
- Experience in EP evaluator software , preferable
- Strong knowledge of validation methodologies, quality assurance principles, and regulatory requirements (e.g., CAP, NYS, CLSI, FDA, ISO, CLIA).
- Excellent leadership and team management skills.
- Proficiency in data analysis and interpretation.
- Exceptional communication and interpersonal skills.
- Ability to work effectively in a global and cross-functional environment.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various 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, LifeWorks, 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, subsidized travel passes, health assessments, among others.
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.
Are you a current ICON Employee? Please click here to apply
-
Regulatory Affairs Specialist II
4 months ago
Cork, Ireland Boston Scientific Full timeLocation: Cork Contract Type: Permanent Reporting to: Senior Manager, Regulatory Affairs Closing Date: 15th August At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are...
-
Cork, Ireland Life Science Recruitment Ltd Full timePrincipal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently recruting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site. This is a permanent role withhybrid working. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and...
-
Public Affairs Manager
1 month ago
Cork, Ireland Cork Chamber of Commerce Full timeRole: Public Affairs Manager Contract Type: Permanent Reporting To: Reporting to the Director of Public & International Affairs Direct Reports: Public Affairs & Communication Executive, Policy & Research Executive About Cork Chamber: Cork Chamber is committed to being a world-leading Chamber of Commerce, delivering on a progressive economic, social and...
-
Public Affairs Manager
2 months ago
Cork, Ireland Statkraft Full timeJob DescriptionIn this new role, you will work with the team to represent Statkraft’s business interests in Ireland. You will be the eyes and ears for changes in policy that may impact our operations, you will support the team to engage with policy makers, and you will help to build Statkraft’s reputation in this key market. Statkraft’s business...
-
Manufacturing Engineering Manager II
1 month ago
Cork, Ireland Boston Scientific Full timeLocation: Cork Contract Type: PermanentReporting to: Senior Manufacturing Engineer Manager Closing Date: 24th October 2024 At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints...
-
QC Laboratory Manager M3
1 month ago
Cork, Ireland Boston Scientific Full timeLocation: Cork Contract Type: PermanentReporting to: Associate Quality DirectorClosing Date: 24th October 2024 At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed...
-
Regulatory Affairs Specialist
1 month ago
Cork, Ireland Stryker European Operations Limited Full timeWork Flexibility: Hybrid The Regulatory Affairs Specialist works closely under direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory...
-
Sourcing Specialist II
4 months ago
Cork, Ireland Boston Scientific Full timeLocation: Cork Req Number: 588141 Contract type: Permanent At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation...
-
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 850 of whom...
-
Laboratory Technician II
4 weeks ago
Cork, Ireland Boston Scientific Full timeAt Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a...
-
Supplier Quality Engineer II
4 months ago
Cork, Ireland Boston Scientific Full timeLocation: Cork Contract Type: Permanent Reporting to: Senior Supplier Quality Engineer Closing Date: 20th August At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints...
-
Supplier Engineer
4 months ago
Cork, Ireland Boston Scientific Full timeOur Mission: At Boston Scientific, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the...
-
Maintenance Technician II
4 months ago
Cork, Ireland Boston Scientific Full timeLocation: Cork Req Number: 584410 Shift: Days Contract type: Permanent At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require...
-
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Are you interested in Chemistry, Manufacturing and Controls (CMC) drug development, technical writing, and leading cross functional teams? The purpose of the Scientific Communications Associate – CMC Regulatory role is to work with cross-functional,...
-
Process Engineer
4 months ago
Cork, Ireland Thermo Fisher Scientific Full time: Provide technical support to the manufacturing process, ensuring customer requirements and site metrics are achieved. Lead and support plant activities and technical investigations. Generate documentation for process start-up activities. Use existing technologies and global information systems to analyze and improve product throughput and...
-
Engineer III, QA
3 months ago
Cork, Ireland Thermo Fisher Scientific Full time: Perform duties with the highest standard of accuracy and in strict accordance with our Quality Management System requirements and Global Quality Policies. Fully engage in our site's quality initiatives and ensure alignment with all relevant standards. Attend training sessions and complete assessments to improve your skills and knowledge. Follow GMP...
-
R&D Eng
2 weeks ago
Cork, Ireland Boston Scientific Full timeAdditional Locations: Ireland-Clonmel; Ireland-GalwayDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges....
-
Cork, Ireland Pharmiweb Full timeVP, Global Regulatory Affairs Consulting Services/ Ireland ,UK, Spain, Poland / Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. This is an...
-
Senior Manager
5 months ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
-
Advisor / Senior Advisor - GPS Global Medical Review
6 months ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Organisation Overview: At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring...
