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Regulatory CMC Strategist at ICON plc
, , United States - Full Time
Skills Needed
Regulatory Strategy, Cmc Expertise, Analytical Skills, Strategic Thinking, Communication Skills, Problem Solving, Risk Management, Regulatory Compliance, Documentation, Negotiation, Collaboration, Project Management, Global Regulatory Requirements, Lifecycle Management, Drug Development, Quality Management
Specialization
Candidates should possess a bachelor's or advanced degree in a relevant scientific or regulatory discipline and have 5-8 years of proven experience in regulatory strategy within the pharmaceutical or CRO industry. In-depth knowledge of global regulatory requirements and strong analytical and communication skills are essential.
Experience Required
Minimum 5 year(s)
CTA Base at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Patient Recruitment, Regulatory Guidelines, Problem Solving, Attention To Detail, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Collaboration, Study Documentation, Data Management, Clinical Operations, Biometrics
Specialization
A bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field is required. Previous experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry, is also necessary.
Pharmacometrician (Client dedicated | Fully remote) at ICON plc
Burlington, Ontario, United States - Full Time
Skills Needed
Pharmacometric Analysis, Regulatory Strategy, Clinical Development, Problem Solving, Communication, Team Collaboration, Data Management, Model Based Methods, Pharmacology, Biology, Mathematics, Statistics, Scientific Writing, Attention To Detail, Drug Development, Efficacy Assessment
Specialization
Candidates must have a Ph.D. in a relevant field and at least 3 years of relevant work experience, including 2 years applying model-based methods in drug development. Expert knowledge in pharmacometrics and effective communication skills are essential.
Experience Required
Minimum 2 year(s)
Payment Specialist at ICON plc
, , United States - Full Time
Skills Needed
Grant Management, Grant Writing, Research Skills, Analytical Skills, Communication Skills, Detail Oriented, Deadline Management
Specialization
A bachelor's degree in a relevant field is required, along with previous experience in grant writing or management. Strong research, analytical, and communication skills are essential for this position.
Experience Required
Minimum 2 year(s)
CTA Base at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Patient Recruitment, Regulatory Guidelines, Problem Solving, Attention To Detail, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Collaboration, Study Documentation, Data Management, Biometrics, Clinical Operations
Specialization
A bachelor's or advanced degree in Life Sciences or a related field is required, along with previous experience in clinical research or healthcare. Strong organizational skills and effective communication abilities are essential for this role.
CTA Base at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Patient Recruitment, Regulatory Guidelines, Problem Solving, Attention To Detail, Time Management, Communication Skills, Interpersonal Skills, Collaboration, Study Documentation, Data Management, Biometrics, Clinical Operations, Study Close Out Activities
Specialization
A bachelor's or advanced degree in Life Sciences or a related field is required, along with previous experience in clinical research or healthcare. Strong organizational skills and effective communication abilities are essential.
PQC Administrator at Next Plc
Wakefield, England, United Kingdom - Full Time
Skills Needed
Administrative Support, Data Management, Rework Coordination, Procurement, Inventory Management, Reporting, Microsoft Office Suite, Google Workspace, Asana, Attention To Detail, Organizational Skills, Multitasking, Communication Skills, Interpersonal Skills, Team Collaboration, Quality Control
Specialization
Candidates should have proven experience in administrative roles, preferably in a quality control or manufacturing environment. Strong proficiency in Microsoft Office Suite and excellent organizational skills are essential.
Experience Required
Minimum 2 year(s)
CRA I at ICON plc
Sydney, New South Wales, Australia - Full Time
Skills Needed
Clinical Trials, Data Analysis, Regulatory Compliance, Communication, Teamwork, Stakeholder Management, Medical Data Review, Study Documentation, Feasibility Studies, Patient Safety, Flexibility, Travel
Specialization
Candidates should have a university degree in medicine, science, or equivalent, along with knowledge of ICH-GCP guidelines. Completion of CRA training and excellent communication skills in English are also required.
Clinical Study Administrator at ICON plc
Kuala Lumpur, Kuala Lumpur, Malaysia - Full Time
Skills Needed
Clinical Trials, Regulatory Compliance, Documentation Management, Communication Skills, Organizational Skills, Team Collaboration, Medical Data Interpretation, Clinical Research
Specialization
A bachelor's degree in a scientific or healthcare-related field is required, along with prior experience or a strong interest in clinical research. Knowledge of clinical trial processes and excellent organizational and communication skills are also necessary.
Winter Support Team - Omagh (N106829) at Next Plc
Omagh, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Team Player, Organized, Dependable, Quick Learner
Specialization
No prior retail experience is necessary, but a positive attitude and willingness to work are essential. Candidates should be comfortable in a busy environment and committed to team goals.
CRA II at ICON plc
Singapore, , Singapore - Full Time
Skills Needed
Clinical Trials, Data Integrity, Patient Safety, Protocol Compliance, Communication Skills, Organizational Skills, Medical Data Interpretation, Collaboration, Data Review, Query Resolution, Study Documentation, Regulations Knowledge, Ich Gcp Guidelines, Independent Work, Team Collaboration, Attention To Detail, Travel
Specialization
Candidates must have a Bachelor's degree in a scientific or healthcare-related field and a minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes and strong organizational and communication skills are also required.
Experience Required
Minimum 2 year(s)
Clinical Research Associate at ICON plc
Singapore, , Singapore - Full Time
Skills Needed
Clinical Trials, Data Analysis, Monitoring Experience, Ich Gcp Guidelines, Communication Skills, Stakeholder Management, Regulatory Compliance, Medical Data Evaluation
Specialization
Candidates should have at least 2 years of monitoring experience as a CRA and a university degree in medicine, science, or a related field. Knowledge of ICH-GCP guidelines and excellent communication skills in English are also required.
Experience Required
Minimum 2 year(s)
Clinical Trial Assistance at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Regulatory Guidelines, Problem Solving, Communication, Interpersonal Skills, Organizational Skills, Time Management, Attention To Detail
Specialization
Candidates should have a Bachelor's or advanced degree in Life Sciences or a related field, along with previous experience in clinical research or healthcare. Strong organizational skills and attention to detail are essential.
Senior Clinical Research Associate at ICON plc
, , Turkey - Full Time
Skills Needed
Clinical Trial Management, Regulatory Compliance, Good Clinical Practice, Data Integrity, Site Management, Problem Solving, Communication, Interpersonal Skills, Stakeholder Management, Training, Monitoring Practices, Organizational Skills
Specialization
Candidates should possess an advanced degree in a relevant field and extensive experience as a Clinical Research Associate. Strong organizational skills and the ability to manage multiple sites and projects are essential.
Experience Required
Minimum 5 year(s)
Team Member - Belfast Donegal Place (N106924) at Next Plc
Belfast, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Communication, Teamwork, Flexibility, Problem Solving, Time Management, Sales, Stock Management
Specialization
The ideal candidate should be a great communicator with a friendly and calm demeanor, even during busy times. They should be flexible, supportive, and eager to take on a varied and fast-paced role.
Senior Biostatistician II at ICON plc
, , United States - Full Time
Skills Needed
Biostatistics, Sas, R, Statistical Analysis, Clinical Trials, Protocol Development, Statistical Reporting, Regulatory Experience, Leadership, Time Management, Statistical Consulting, Mentoring, Process Improvement, Client Interaction, Budget Management, Presentation Skills
Specialization
Candidates must have a Master's degree or Ph.D. in Biostatistics, Statistics, or a related field, along with 7+ years of biostatistical experience. Experience leading Phase II-III studies and regulatory experience is preferred.
Experience Required
Minimum 5 year(s)
Oncology CRA I at ICON plc
Seoul, , South Korea - Full Time
Skills Needed
Clinical Research, Data Analysis, Regulatory Compliance, Communication, Stakeholder Management, Medical Data Evaluation, Travel, Study Coordination, Feasibility Studies, Patient Safety, Ich Gcp Guidelines, Documentation, Study Monitoring, Social Skills, Study Cost Efficiency
Specialization
A university degree in medicine, science, or equivalent is required, along with knowledge of ICH-GCP guidelines. Excellent written and verbal communication skills in English and the ability to travel at least 60% of the time are also necessary.
Ancillary Supplies Coordinator at ICON plc
, , United States - Full Time
Skills Needed
Supply Chain Management, Logistics, Inventory Management, Regulatory Compliance, Project Management, Data Analysis, Communication Skills, Interpersonal Skills, Stakeholder Management, Vendor Management, Clinical Trials, Procurement, Problem Solving, Strategic Planning, Team Collaboration, Best Practices
Specialization
Candidates should possess an advanced degree in a relevant field and significant experience in managing clinical supply chains. Strong organizational, project management, and communication skills are essential for success in this role.
Experience Required
Minimum 5 year(s)
Team Member - Belfast Boucher Retail Park (N103557) at Next Plc
Belfast, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Communication, Teamwork, Flexibility, Problem Solving, Stock Management, Sales, Product Knowledge
Specialization
The ideal candidate is a great communicator who is friendly, calm, and efficient, even during busy times. They should be excited about a varied and fast-paced job and be willing to go the extra mile.
Team Member - Ballymena (N99103) at Next Plc
Ballymena, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Communication, Teamwork, Flexibility, Problem Solving, Product Knowledge, Stock Management, Time Management
Specialization
The ideal candidate is a great communicator who is friendly, calm, and efficient, even during busy times. They should be excited about a varied and fast-paced job and be willing to go the extra mile.
Regulatory CMC Strategist at ICON plc
, , United States -
Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

0.0

Posted On

25 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Strategy, CMC Expertise, Analytical Skills, Strategic Thinking, Communication Skills, Problem Solving, Risk Management, Regulatory Compliance, Documentation, Negotiation, Collaboration, Project Management, Global Regulatory Requirements, Lifecycle Management, Drug Development, Quality Management

Industry

Biotechnology Research

Description
Regulatory CMC Stategist 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 We are currently seeking a Manager, Regulatory Strategy with regulatory CMC expertise to join our diverse and dynamic team. As a Manager, Regulatory Strategy at ICON, you will play a pivotal role in shaping and implementing strategic regulatory plans to the development and approval of innovative treatments and therapies. Your expertise will be crucial in navigating complex regulatory landscapes and ensuring compliance with global regulatory requirements. The role will work with a client focusing on: The Strategist, Global Regulatory Affairs CMC is responsible and accountable for: Defining, coordinating and implementing global CMC regulatory strategies for product- specific development and life-cycle activities Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets. The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters. Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval. Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives. Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals Facilitates the communication and flow of regulatory information (regulatory frame work, scope and project timelines) to all relevant stakeholders. Identifies and recommends the most effective CMC regulatory strategies to assure a first pass regulatory approval of initial application and lifecycle supplements/variations Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions in line with client's operating model with the purpose to obtain, maintain and extend BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs. In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams. In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully documented in the respective quality management system. Provides tactical and strategic regulatory input and guidance, including active partici- pation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards reates high quality, compliant regulatory CMC documents within defined timelines as per BU objectives Participates in discussions and negotiations with regulatory authorities, agents, business partners, proactively and as required Assists in the conduct of regulatory agency inspections and compliance audits Your Profile Bachelor's or advanced degree in a relevant scientific or regulatory discipline. Proven experience in regulatory strategy within the pharmaceutical or CRO industry (5-8 years). In-depth knowledge of global regulatory requirements for drug development and submissions. Strong analytical and strategic thinking skills, with the ability to navigate complex regulatory scenarios. Excellent communication skills, fostering partnership across diverse teams. 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.
Responsibilities
The Regulatory CMC Strategist will define, coordinate, and implement global CMC regulatory strategies for product-specific development and lifecycle activities. This role involves liaising with regulatory authorities and managing high-quality regulatory documentation to ensure compliance and successful submissions.
Regulatory CMC Strategist at ICON plc
, , United States - Full Time
Skills Needed
Regulatory Strategy, Cmc Expertise, Analytical Skills, Strategic Thinking, Communication Skills, Problem Solving, Risk Management, Regulatory Compliance, Documentation, Negotiation, Collaboration, Project Management, Global Regulatory Requirements, Lifecycle Management, Drug Development, Quality Management
Specialization
Candidates should possess a bachelor's or advanced degree in a relevant scientific or regulatory discipline and have 5-8 years of proven experience in regulatory strategy within the pharmaceutical or CRO industry. In-depth knowledge of global regulatory requirements and strong analytical and communication skills are essential.
Experience Required
Minimum 5 year(s)
CTA Base at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Patient Recruitment, Regulatory Guidelines, Problem Solving, Attention To Detail, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Collaboration, Study Documentation, Data Management, Clinical Operations, Biometrics
Specialization
A bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field is required. Previous experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry, is also necessary.
Pharmacometrician (Client dedicated | Fully remote) at ICON plc
Burlington, Ontario, United States - Full Time
Skills Needed
Pharmacometric Analysis, Regulatory Strategy, Clinical Development, Problem Solving, Communication, Team Collaboration, Data Management, Model Based Methods, Pharmacology, Biology, Mathematics, Statistics, Scientific Writing, Attention To Detail, Drug Development, Efficacy Assessment
Specialization
Candidates must have a Ph.D. in a relevant field and at least 3 years of relevant work experience, including 2 years applying model-based methods in drug development. Expert knowledge in pharmacometrics and effective communication skills are essential.
Experience Required
Minimum 2 year(s)
Payment Specialist at ICON plc
, , United States - Full Time
Skills Needed
Grant Management, Grant Writing, Research Skills, Analytical Skills, Communication Skills, Detail Oriented, Deadline Management
Specialization
A bachelor's degree in a relevant field is required, along with previous experience in grant writing or management. Strong research, analytical, and communication skills are essential for this position.
Experience Required
Minimum 2 year(s)
CTA Base at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Patient Recruitment, Regulatory Guidelines, Problem Solving, Attention To Detail, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Collaboration, Study Documentation, Data Management, Biometrics, Clinical Operations
Specialization
A bachelor's or advanced degree in Life Sciences or a related field is required, along with previous experience in clinical research or healthcare. Strong organizational skills and effective communication abilities are essential for this role.
CTA Base at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Patient Recruitment, Regulatory Guidelines, Problem Solving, Attention To Detail, Time Management, Communication Skills, Interpersonal Skills, Collaboration, Study Documentation, Data Management, Biometrics, Clinical Operations, Study Close Out Activities
Specialization
A bachelor's or advanced degree in Life Sciences or a related field is required, along with previous experience in clinical research or healthcare. Strong organizational skills and effective communication abilities are essential.
PQC Administrator at Next Plc
Wakefield, England, United Kingdom - Full Time
Skills Needed
Administrative Support, Data Management, Rework Coordination, Procurement, Inventory Management, Reporting, Microsoft Office Suite, Google Workspace, Asana, Attention To Detail, Organizational Skills, Multitasking, Communication Skills, Interpersonal Skills, Team Collaboration, Quality Control
Specialization
Candidates should have proven experience in administrative roles, preferably in a quality control or manufacturing environment. Strong proficiency in Microsoft Office Suite and excellent organizational skills are essential.
Experience Required
Minimum 2 year(s)
CRA I at ICON plc
Sydney, New South Wales, Australia - Full Time
Skills Needed
Clinical Trials, Data Analysis, Regulatory Compliance, Communication, Teamwork, Stakeholder Management, Medical Data Review, Study Documentation, Feasibility Studies, Patient Safety, Flexibility, Travel
Specialization
Candidates should have a university degree in medicine, science, or equivalent, along with knowledge of ICH-GCP guidelines. Completion of CRA training and excellent communication skills in English are also required.
Clinical Study Administrator at ICON plc
Kuala Lumpur, Kuala Lumpur, Malaysia - Full Time
Skills Needed
Clinical Trials, Regulatory Compliance, Documentation Management, Communication Skills, Organizational Skills, Team Collaboration, Medical Data Interpretation, Clinical Research
Specialization
A bachelor's degree in a scientific or healthcare-related field is required, along with prior experience or a strong interest in clinical research. Knowledge of clinical trial processes and excellent organizational and communication skills are also necessary.
Winter Support Team - Omagh (N106829) at Next Plc
Omagh, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Team Player, Organized, Dependable, Quick Learner
Specialization
No prior retail experience is necessary, but a positive attitude and willingness to work are essential. Candidates should be comfortable in a busy environment and committed to team goals.
CRA II at ICON plc
Singapore, , Singapore - Full Time
Skills Needed
Clinical Trials, Data Integrity, Patient Safety, Protocol Compliance, Communication Skills, Organizational Skills, Medical Data Interpretation, Collaboration, Data Review, Query Resolution, Study Documentation, Regulations Knowledge, Ich Gcp Guidelines, Independent Work, Team Collaboration, Attention To Detail, Travel
Specialization
Candidates must have a Bachelor's degree in a scientific or healthcare-related field and a minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes and strong organizational and communication skills are also required.
Experience Required
Minimum 2 year(s)
Clinical Research Associate at ICON plc
Singapore, , Singapore - Full Time
Skills Needed
Clinical Trials, Data Analysis, Monitoring Experience, Ich Gcp Guidelines, Communication Skills, Stakeholder Management, Regulatory Compliance, Medical Data Evaluation
Specialization
Candidates should have at least 2 years of monitoring experience as a CRA and a university degree in medicine, science, or a related field. Knowledge of ICH-GCP guidelines and excellent communication skills in English are also required.
Experience Required
Minimum 2 year(s)
Clinical Trial Assistance at ICON plc
, , United States - Full Time
Skills Needed
Clinical Trials, Data Collection, Regulatory Guidelines, Problem Solving, Communication, Interpersonal Skills, Organizational Skills, Time Management, Attention To Detail
Specialization
Candidates should have a Bachelor's or advanced degree in Life Sciences or a related field, along with previous experience in clinical research or healthcare. Strong organizational skills and attention to detail are essential.
Senior Clinical Research Associate at ICON plc
, , Turkey - Full Time
Skills Needed
Clinical Trial Management, Regulatory Compliance, Good Clinical Practice, Data Integrity, Site Management, Problem Solving, Communication, Interpersonal Skills, Stakeholder Management, Training, Monitoring Practices, Organizational Skills
Specialization
Candidates should possess an advanced degree in a relevant field and extensive experience as a Clinical Research Associate. Strong organizational skills and the ability to manage multiple sites and projects are essential.
Experience Required
Minimum 5 year(s)
Team Member - Belfast Donegal Place (N106924) at Next Plc
Belfast, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Communication, Teamwork, Flexibility, Problem Solving, Time Management, Sales, Stock Management
Specialization
The ideal candidate should be a great communicator with a friendly and calm demeanor, even during busy times. They should be flexible, supportive, and eager to take on a varied and fast-paced role.
Senior Biostatistician II at ICON plc
, , United States - Full Time
Skills Needed
Biostatistics, Sas, R, Statistical Analysis, Clinical Trials, Protocol Development, Statistical Reporting, Regulatory Experience, Leadership, Time Management, Statistical Consulting, Mentoring, Process Improvement, Client Interaction, Budget Management, Presentation Skills
Specialization
Candidates must have a Master's degree or Ph.D. in Biostatistics, Statistics, or a related field, along with 7+ years of biostatistical experience. Experience leading Phase II-III studies and regulatory experience is preferred.
Experience Required
Minimum 5 year(s)
Oncology CRA I at ICON plc
Seoul, , South Korea - Full Time
Skills Needed
Clinical Research, Data Analysis, Regulatory Compliance, Communication, Stakeholder Management, Medical Data Evaluation, Travel, Study Coordination, Feasibility Studies, Patient Safety, Ich Gcp Guidelines, Documentation, Study Monitoring, Social Skills, Study Cost Efficiency
Specialization
A university degree in medicine, science, or equivalent is required, along with knowledge of ICH-GCP guidelines. Excellent written and verbal communication skills in English and the ability to travel at least 60% of the time are also necessary.
Ancillary Supplies Coordinator at ICON plc
, , United States - Full Time
Skills Needed
Supply Chain Management, Logistics, Inventory Management, Regulatory Compliance, Project Management, Data Analysis, Communication Skills, Interpersonal Skills, Stakeholder Management, Vendor Management, Clinical Trials, Procurement, Problem Solving, Strategic Planning, Team Collaboration, Best Practices
Specialization
Candidates should possess an advanced degree in a relevant field and significant experience in managing clinical supply chains. Strong organizational, project management, and communication skills are essential for success in this role.
Experience Required
Minimum 5 year(s)
Team Member - Belfast Boucher Retail Park (N103557) at Next Plc
Belfast, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Communication, Teamwork, Flexibility, Problem Solving, Stock Management, Sales, Product Knowledge
Specialization
The ideal candidate is a great communicator who is friendly, calm, and efficient, even during busy times. They should be excited about a varied and fast-paced job and be willing to go the extra mile.
Team Member - Ballymena (N99103) at Next Plc
Ballymena, Northern Ireland, United Kingdom - Full Time
Skills Needed
Customer Service, Communication, Teamwork, Flexibility, Problem Solving, Product Knowledge, Stock Management, Time Management
Specialization
The ideal candidate is a great communicator who is friendly, calm, and efficient, even during busy times. They should be excited about a varied and fast-paced job and be willing to go the extra mile.