[Remote] Country Approval Specialist & Site Contract Specialist at Thermo Fisher Scientific

Mexico

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, Life SciencesIndustries

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 (comparable to 2+ years)
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment

Responsibilities

Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
Provides, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients
Provides project specific local SIA services and coordination of these projects
Acts as key-contact at country level for either Ethical or Regulatory submission-related activities, including contact with investigators
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
Achieves PPD’s target cycle times for site activations
Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
Develops country specific Patient Information Sheet/Informed Consent form documents
Assists with grant budgets(s) and payment schedules negotiations with sites
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines
Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process
Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions per company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes
Ensures compliance to established negotiation parameters, contractual process and client expectations
Ensures compliance of budgetary guidance, templates and process
Identifies and assesses legal, financial and operational risks and brings up to appropriate level of the organization per established processes
Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels
Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines

Skills

Regulatory Submissions

Country Approvals

MoH Approvals

EC Approvals

Contract Negotiation

Site Contracts

Informed Consent Forms

Feasibility Coordination

Trial Tracking

Study File Management

Grant Budgets

Site Initiation Activities

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