Clinical Trial Associate 3 (CTA 3) Job at iconplc (Mexico City)

Regulatory Affairs Manager

The Regulatory Affairs Manager at Amgen ensures the company’s compliance with al...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate Degree
Master's Degree and 3 years of Regulatory CMC or related technical experience
Bachelor's Degree and 5 years of Regulatory CMC or related technical experience
Associates degree and 10 years of Regulatory CMC or related technical experience

Job Responsibility

Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
Support development of global dossiers for CMC content of new marking applications (MAA), new clinical trials (CTA), variations and amendments to existing MAA/ CTAs
Development of post-approval submissions including maintenance of applications
Support Change Management activities
Respond to regulatory agency questions
Liaise with the Global RA CMC product lead, ROOTS representatives, and other functions in development, operations, and commercial to ensure alignment of global regulatory strategies and timing, execution
Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current
Participate as an active member of cross-functional teams

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Site Management Associate II

As a Site Management Associate II (SMA II) at ICON, you will support the managem...

Location

Argentina , Buenos Aires

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in health sciences or administrative programs
At least 3 years relevant experience /strong understanding of the scope of clinical trial administration
Advanced English
Leadership skills and great potential for development
Proactive, organized, tech savvy, attentive to details

Job Responsibility

TMF filing, quality, maintenance, compliance, and oversight
Lead the development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
Maintain Registries and systems as required
Support of site payment services, patient compensation services and other local payments as required
Provide reporting to support management of clinical trials
Provide support with audit and inspection readiness activities
Lead regional activities within the team and the client
Provide support to CTA managers for development and implementation of on-boarding training for new hires: Mentor new hires and entry level CTAs
Serve as SME for key CTA processes, systems and tasks
Work with CTA managers to identify continuous improvement opportunities to enhance operational efficiencies

What we offer

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

Fulltime

Manager, Regulatory Affairs

Location

South Korea , Seoul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s in Pharmacy or equivalent in a health-related field plus 6-7 years of clinical trials experience
within the total years of experience, at least 3-4 years of regulatory submissions experience is required
Strong technical knowledge and 3-4 years of experience in executing Clinical Trial Applications in Korea
(preferred) Experience in preparing, attending and responding to GCP Inspection
Good written and verbal communication skills in English
Degree and in-depth regulatory experience and/or related to the country
Depth knowledge of country legislation and regulations relating to medicinal products
Ability to conceptualize, develop and manage timelines, including its updates
Ability to delegate and make decisions, including risk-based ones
Ability to manage multiple projects and priorities

Job Responsibility

Efficiently end-to-end manages Clinical Trials Regulatory submission in Korea for new and ongoing project(s) or programs, including and not limited to initial applications, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed
Develops, with the input of importer of record, study specific import licenses approvals and keeps it updated
Monitors efficiency, quality and adherence to project timelines, SOPs and local regulations
Attends to regulatory inspections and corporate audits, representing the RA function
Communicates overall regulatory status to internal teams and service providers
Attends to project meetings with cross functional department leads to provide strategy, timelines and requirements for regulatory submissions and approvals
Works with internal team members to establish and clarify regulatory requirements
Responsible for clinical trial regulatory intelligence, including regular updates to databases
Coordinate with local and global team CTA pre-submission meetings with Agency, if needed
Where applicable, provides work instructions to related team members in preparation of regulatory submissions, timeline estimations, issues resolution, etc

Fulltime

Senior Associate Regulatory Affairs

Join our team at AMGEN Capability Center Portugal. Amgen's Regional Regulatory A...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree or Bachelor’s degree (scientific area) and 3 years of directly related experience
Demonstrated experience in clinical trial regulatory affairs
Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) is ideal
Depth knowledge of EU legislation and regulations relating to medicinal products is ideal
Adaptability and strong English communication skills, both oral and written

Job Responsibility

Execute the EU regulatory strategy and EU regulatory plans
Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities
Use of Amgen systems and document management
Ensure and support regulatory product compliance
Work with policies and SOPs
Build effective relationships and communication paths across local and functional organizations
Enable efficiencies and seamless execution across the region countries

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Site Manager

We have an exciting opportunity for a Site Manager to join our growing Refurbish...

Location

United Kingdom , Nottingham

Salary:

Not provided

Social Value Portal Ltd

Expiration Date

Until further notice

Requirements

Experienced Site Manager with a strong track record in planned maintenance and refurbishment
excellent organisational and communication skills
strong focus on customer service
confidence in using IT systems
proactive approach to health, safety and environmental standards
effectively managing subcontractors
ensuring all processes and compliance requirements are met
confident and self-motivated

Job Responsibility

Delivering high-quality refurbishment works while ensuring excellent customer satisfaction, particularly within occupied homes
managing refurbishment programmes within the social housing sector
planning and coordinating works from start to finish
identifying key information to develop effective programmes, including methods, phasing and timelines
ensuring delivery remains on track
taking ownership of site operations
maintaining accurate records
monitoring progress
ensuring the right labour, materials and resources are in place to meet contractual requirements
working closely with residents, colleagues and the supply chain

What we offer

Bonus entitlement based on performance KPIs
Holidays - 26 days
Life Assurance
Pension
Private medical insurance
Ability to purchase additional holiday
Access to discount portal
Cycle to Work scheme and the Lovell Way to EV
Digital GP
Employee assistance programme

Fulltime

Quantity Surveyor

Rydon Maintenance Ltd are now seeking an experienced Quantity Surveyor to manage...

Location

United Kingdom , Greenhithe

Salary:

Not provided

Social Value Portal Ltd

Expiration Date

Until further notice

Requirements

Experienced Quantity Surveyor with demonstrable experience gained ideally within a housing maintenance environment (reactive/responsive repairs, cyclical decorations and/or lifecycle repairs)
Candidates with experience in a Quantity Surveying role within the Refurbishment of social housing stock will also be considered
NHF schedule of rates experience and knowledge of property services contracts for local authorities

Job Responsibility

Control of expenditure
Timely Purchasing and negotiating Sub Contract, Material and Plant orders
Reconcile cost/value reports & profit forecasts
Ensure Subcontractors and Suppliers are approved and meet company standards prior to procurement
Ensuring value for money and financial assessments
Manage day to day cost control & monitoring and reporting
Process Subcontractor requests for payment via application & invoice

What we offer

Competitive starting salary
Car allowance of £4,872 per annum
25 days holiday with the ability to increase up to 30 days
Access to an employee discount scheme
Company pension, life assurance and income protection
Flexible benefits including Critical Illness, DenPlan, Private Medical Insurance and Cycle to work schemes
Health and wellness benefits such as free flu vaccinations, access to an Employee Assistance and Wellbeing Programme, BUPA Health & Wellbeing Plans, access to our Health and Wellbeing portal
Opportunities to progress your career across the business
Full training, ongoing coaching and support

Fulltime

Agent - Reservations

Process all reservation requests, changes, and cancellations received by phone, ...

Location

Macau , Macau

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or G.E.D. equivalent
No related work experience
No supervisory experience
None

Job Responsibility

Process all reservation requests, changes, and cancellations received by phone, fax, or mail
Identify guest reservation needs and determine appropriate room type
Verify availability of room type and rate
Explain guarantee, special rate, and cancellation policies to callers
Accommodate and document special requests
Answer questions about property facilities/services and room accommodations
Follow sales techniques to maximize revenue
Input and access data in reservation system
Indicate special room reservation types (e.g., complimentary rooms, employee discounts, travel agent inspection rates, and wholesale reservations) by inputting the correct code and rate into the reservation system
Follow proper escalation procedures when addressing guest concerns

Fulltime

Mechanic C

As a Mechanic C, you’ll support the upkeep of production and facility equipment ...

Location

United States , Franklin Park

Salary:

28.65 USD / Hour

Nestle Health Science

Expiration Date

Until further notice

Requirements

High school diploma or GED required
technical degree preferred
2+ years of maintenance experience, including manufacturing
Mechanical/electrical trade background preferred
Working knowledge of CMMS preferred
Able to lift up to 50 lbs and move throughout your shift
Comfortable working around powders, chemicals, and food allergens
Flexible to work overtime based on business needs
Must have basic proficiency of English language to comply with verbal and written directions, signs, policies and procedures

Job Responsibility

Perform mechanical, electrical, and electronic repairs across production and facility equipment
Troubleshoot and maintain pneumatic, hydraulic, and steam systems
Support equipment changeovers and line adjustments
Clean, lubricate, and inspect machinery for wear or damage
Monitor and maintain plant systems (boilers, compressors, HVAC, etc.)
Use manuals, drawings, and technical resources to diagnose issues
Assist with emergency repairs and scheduled maintenance
Collaborate with teams to solve problems and improve performance
Follow safety rules, Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs), and company policies
Perform other duties as assigned

What we offer

Performance-based incentives
401k with Company match
Healthcare coverage
Broad range of other benefits
$3.00/hour shift differential

Fulltime

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Clinical Trial Associate 3 (CTA 3)

Job Description

Job Responsibility

Requirements

What we offer

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