FSP Country Approval Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Country Approval Specialist and make an impact at the forefront of innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What you will do:

Prepare, review and coordinate 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 EU/global submission strategy

Provide local regulatory strategy advice (MoH &/or EC) to internal clients

Provide project specific local start-up services and coordination of these projects

May have contact with investigators for submission related activities

Serve as key-contact at country level for either Ethical or Regulatory submission-related activities

Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation

Achieve target cycle times for site activation

Prepare the regulatory compliance review packages, if applicable

Develop country specific Patient Information Sheet/Informed Consent form documents

May assist with grant budget(s) and payment schedules negotiations with sites

May support the feasibility activities, as required, in accordance with agreed timelines

Enter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely manner

Ensure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPs

Maintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services provided

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

Working conditions and environment:

Work is performed in an office environment

Exposure to electrical office equipment