[Remote] Amendment Implementation Specialist at Thermo Fisher Scientific

Brazil

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

Requirements

Ability to support amendment implementation strategy at country, site, regional, or global levels
Knowledge of amendment scope, classification, and timelines
Proficiency in Clarity system for supporting country resource requests and updating forecasting/actuals
Capability to collaborate with project teams on amendment planning
Skills in tracking actions and facilitating updates in applicable systems
Experience scheduling and conducting progress check calls
Familiarity with updating Principal Investigator Amendment Notification and Amendment Implementation Letters
Ability to liaise with Regulatory Affairs Leads and project teams on submission requirements and timelines
Competence in preparing and distributing Amendment Progress Report and study reports
Skills in identifying risks and supporting contingency planning for amendments
Ability to introduce roles and responsibilities to project teams
Capability to request access to study-related systems

Responsibilities

Supports the amendment implementation strategy at country and site levels, within a region or globally
Supports understanding of amendment scope, classification, and timelines
Supports requests of country resources in Clarity
Collaborates with project teams on amendment planning
Discusses financial coverage for an amendment with the Project Lead
Tracks amendment related actions and facilitates updates within applicable system(s)
Schedules and conducts progress check calls with project teams
Updates Principal Investigator Amendment Notification and Amendment Implementation Letters
Liaises with the Regulatory Affairs Leads and project teams to assess amendment submission requirements and country submission timelines
Prepares and distributes the Amendment Progress Report and other applicable study reports to project teams to act on compliance gaps as applicable, directly in systems, providing a deadline for feedback
Updates forecasting and actuals for amendment related units according to Clarity monthly deadlines
Informs project team members when amendment activities have been completed
Supports risk identification and contingency planning pertaining to amendments
Introduces roles and responsibilities to project team
Requests access to study related systems

Skills

Key technologies and capabilities for this role

ClarityProject ManagementRegulatory AffairsAmendment ImplementationForecastingRisk ManagementReportingStakeholder CollaborationTimeline ManagementFinancial Tracking

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

What is the work schedule and location for this role?

The work schedule is standard Monday-Friday in an office environment.

What are the main responsibilities for the Amendment Implementation Specialist?

Responsibilities include supporting amendment implementation strategy at country and site levels, collaborating with project teams on planning, tracking actions in systems, liaising with Regulatory Affairs Leads, and updating forecasting and reports.

What systems or tools are used in this role?

The role involves using Clarity for requests and updates, as well as other applicable study-related systems.

What kind of collaboration is expected in this position?

The role requires collaboration with project teams, country resources, Project Leads, Regulatory Affairs Leads, and Principal Investigators on amendment planning, financial discussions, progress calls, and risk identification.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

Land your dream remote job 3x faster with AI

Try Jobo Free