Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Job Description

Position Overview

Participates in the management and preparation, review, and coordination of Country Submissions in line with global submission strategy.

Employment Type

Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.
  • May have contact with investigators for submission-related activities.
  • Acts as a key contact at the country level for either Ethical or Regulatory submission-related activities.
  • 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 the submission process for sites and study are aligned to the critical path for site activation.
  • Achieves PPD’s target cycle times for sites.
  • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
  • May develop country-specific Patient Information Sheet/Informed Consent form documents.
  • May assist with grant budgets 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.

Qualifications

Education and Experience

  • 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, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

  • 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 or independently, under direction, as required.
  • Basic organizational and planning skills.
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.

Salary

  • [Salary information not provided]

Location Type

  • [Location type not provided]

Skills

Regulatory Submissions
MoH Submissions
EC Submissions
Clinical Trials
Regulatory Strategy
Project Coordination
Documentation
Compliance
SOPs

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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