FSP Country Approval Specialist

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

Key-contact at 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 submission process for sites and study are aligned to the critical path for site activation

Achieves PPD’s target cycle times for site

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(s) and payment schedules negotiations with sites

Supports the coordination of feasibility activities, as required, in accordance with agreed timelines

Entes 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 understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Benefits

Fully remote work arrangement

Glassdoor

3.5

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Waltham, Massachusetts, USA

https://www.thermofisher.com

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Qualifications

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

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

Work is performed in an office/ laboratory and/or a clinical environment

Exposure to biological fluids with potential exposure to infectious organisms

Exposure to electrical office equipment

Personal protective equipment required such as protective eyewear, garments and gloves

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Required skills

Regulatory Guidelines, Ethics Committee Regulations, Medical Terminology

Experience

2+ years