Country Approval Specialist

Thermo Fisher Scientific Inc.; São Paulo; Híbrido; BRL 70.000 - 100.000; Tempo integral

Resumo da oferta

Uma empresa reconhecida no setor de ciências da vida está procurando um especialista para coordenação de submissões regulatórias em São Paulo. O candidato ideal deve ter graduação, experiência anterior e habilidades de comunicação. O trabalho inclui gerenciar processos de submissão e garantir a conformidade com as diretrizes regulatórias locais.

Qualificações

• Experiência anterior relevante de 2+ anos.
• Capacidade de trabalhar em equipe ou individualmente.
• Conhecimento de diretrizes regulatórias regionais.

Responsabilidades

• Gerencia e coordena submissões regulatórias locais e estratégias.
• Apoia atividades de viabilidade dentro dos prazos acordados.
• Mantém arquivos e processos de estudo em conformidade.

Conhecimentos

Comunicação oral e escrita

Interpersonal skills

Atenção aos detalhes

Habilidades de negociação

Habilidades computacionais

Domínio da língua inglesa

Conhecimentos básicos em terminologia médica

Organização e planejamento

Formação académica

Graduação ou equivalente

Descrição da oferta de emprego

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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

Essential Functions and Other Job Information:

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.
• Enter 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.

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