[Remote] Amendment Implementation Specialist at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job
Previous experience with managing amendments is essential
Audit/inspection process awareness of relevant rules and guidance documents
Expert knowledge of an application, system or process
Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Analytical skills, ability to comprehend and analyze data, tables, etc
Strong customer focus
Flexibility to reprioritize workload to meet changing project timelines
Knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle
Advanced English (verbal & written)
Good computer skills, proficient in MS Office (Word, Excel, PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Strong collaboration and communication skills
Ability to work in a team or independently as required
Good negotiation skills
Able to work well and efficiently with cross-functional teams
Consistently demonstrates knowledge of the key principles of cross functional project management
Ability to identify and remedy risks related to contractual deliverables and provides appropriate solutions
Demonstrates sound understanding of cross-cultural awareness and is able to adapt appropriately
Comprehensive understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
Demonstrates ability to lead, liaise and coordinate cross-functional project teams
Comprehensive knowledge/understanding of clinical development guidelines and directives

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

Amendment ManagementProject ManagementClarity SystemRisk AssessmentRegulatory AffairsForecastingAudit/InspectionStakeholder CollaborationReportingTimeline Management

Questions & Answers

Common questions about this position

What education and experience are required for the Amendment Implementation Specialist role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous experience that provides the knowledge, skills, and abilities to perform the job, and previous experience with managing amendments is essential.

What key skills are needed for this position?

Key skills include good organizational skills and strong attention to detail, analytical skills to comprehend and analyze data, strong customer focus, advanced English (verbal & written), strong collaboration and communication skills, and good negotiation skills.

Is this a remote position or does it require office work?

The position is based in office environmental conditions with a standard Monday-Friday work schedule.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for the Amendment Implementation Specialist position?

Strong candidates will have prior experience managing amendments, expert knowledge of clinical trial systems or processes, knowledge of ICH GCP and SOPs, proficiency in MS Office, and the ability to collaborate effectively with cross-functional teams while handling multiple tasks with strong attention to detail.

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.

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