SP l São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista
Farmacêutico
Responsabilidades
- Support the preparation and compilation of local regulatory submissions to ANVISA related to the clinical development dossier and clinical trial applications for drugs, biologics, advanced therapies and devices
- Interaction with sponsors, internal teams and regulatory agencies
- Review and assess clinical trial regulatory documents
- Enters and maintains trial status information relating to RA activities onto PPD tracking databases in an accurate and timely manner
- Ensures the local country study files and filing processes are maintained as per PPD WPDs or applicable client SOPs
- Participation in project team meetings
- Development and implementation of project-specific processes
- Attendance in meetings with local associations and participation in initiatives to foster clinical trials in Brazil
Requisitos
- What the role requires you to have:
- Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the local and global clinical trials landscape
- Knowledge, Skills and Abilities:
- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Capable of working independently on the assigned tasks
- Good understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative and problem-solving skills
