
Regulatory Affairs, Study Start Up Specialist
3 semanas atrás
**ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED**
**Essential Functions**:
- Assist/Advise project teams on all regulatory requirements for clinical studies
- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
- Review and adapt study specific documents according to each country and site requirements
- Perform IRB/EC (CA) and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements
- Receive and process study documentation from sites, check content and quality as well as completeness
- Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during document content quality review
- Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
- Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
- Assist in preparation, quality check, and filing of site adapted ICF according to local requirements
- Prepare and QC Clinical Trial Application forms (e.g., CTA, XML) where applicable
- Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
- Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
- Compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
- Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
- Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
- Assist with preparation for Sponsor or Agency audits and inspections
- Assist with QC and QA of various study related Regulatory documents and reports
- Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
- Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
- Sites budgets and Sites contracts management, depending on Countries/Regions
**Required Education/Experience**:
- Associate or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- At least of 3 years of relevant pharmaceutical, site, or CRO Regulatory experience
- Experience in Clinical Trials Submissions in several LATAM countries
- Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines.
**Competencies**:
- Ability to work well in a team environment
- Ongoing willingness to learn
- Detail oriented
- Excellent verbal and written communication skills
- Fluent in oral and written English is a must, good Spanish language skills are also needed
- Ability to develop, prioritize, organize, and manage multiple tasks
- Ability to provide superior level of customer service
- Proficient in use of computer and software systems
- Ability to maintain confidentiality
**Why CTI?**
- We support career progression - We have a structured mentoring program to provide the support you need to move forward
- We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
- Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally - We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
- We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
- Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-chan
-
Regulatory Affairs Specialist
Há 4 dias
Rio de Janeiro, Rio de Janeiro, Brasil Shell Tempo inteiro**The Role**:**Company description**As a global energy company operating in a challenging world, we set high standards of performance and ethical behaviors.We are judged by how we act and how we live up to our core values of honesty, integrity, and respect for people.Our Business Principles are based on these.They promote trust, openness, teamwork, and...
-
Ssu & Regulatory Specialist Ii
4 semanas atrás
Rio de Janeiro, Brasil Syneos Health Clinical Tempo inteiro**SSU & Regulatory Specialist II** **-** **(** **22004616** **)** **Description** **Site Start-Up & Regulatory Specialist II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the...
-
Regulatory Affairs Analyst
2 semanas atrás
Rio De Janeiro, Brasil Octapharma Tempo inteiroJob ID: 51465- Location: Jacarepaguá, BR- Job Level: Professionals- Job Category: Sales and Marketing- Employment Type: Permanent position- Career Level: Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins. Working at Octapharma means to have an opportunity to...
-
Technical Regulatory Specialist
Há 2 dias
Rio de Janeiro, Rio de Janeiro, Brasil Bw Energy Tempo inteiroEnsure that the BWE process of regulatory compliance assessment and monitoring is in place.- Ensure that all operational-related contractors and BWE operations in Brazil are recurrently assessed and monitored regarding regulatory requirements.- Ensure that all activities, for which is under this one responsible, are carried out in conformance with laws and...
-
Regulatory Affairs Manager
Há 10 horas
Santana de Parnaíba, São Paulo, Brasil International Flavors & Fragrances Tempo inteiroJob Overview:We are seeking a highly skilled Regulatory Affairs Manager to join our team in Barueri, Brasil. As a key member of our regulatory affairs team, you will play a critical role in ensuring the safe use and compliance of our ingredients and products across the LATAM South Cone Region.Key Responsibilities:Develop and execute regulatory strategies to...
-
Regulatory Affairs and Quality Analyst
3 semanas atrás
Rio De Janeiro, Brasil Octapharma Tempo inteiroJob ID: 57720- Location: Jacarepaguá, BR- Job Level: Professionals- Job Category: Regulatory Affairs- Employment Type: Permanent position- Career Level: Do you want to combine the opportunities that a global company provides with the benefits of a family-owned business? Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading...
-
External Affairs Manager
2 semanas atrás
Rio de Janeiro, Brasil bp Tempo inteiro**Job Profile Summary** - At bp, we’re reimagining energy for people and our planet. We provide heat, light and mobility to customers worldwide. We’re fundamentally transforming what we do with operations working across almost every part of the energy system, we’re leading the way in reducing carbon emissions and developing more sustainable methods for...
-
Clinical Affairs Analyst
Há 3 dias
Rio Preto, São Paulo, Brasil Products and Features Brasil Tempo inteiroHorário: De segunda à sexta, das 8h às 17h48 com 1h de almoçoModalidade: PresencialDescrição:The full clinical affairs analyst is a skilled professional who plans, substantiates, builds and conducts a range of clinical affairs activities, including medical writing and ethical/regulatory submissions as required, in territories with similar regulatory...
-
Clinical Affairs Analyst
4 semanas atrás
São José do Rio Preto, Brasil P&F Products & Features Gmbh Tempo inteiroHorário: De segunda à sexta, das 8h às 17h48 com 1h de almoçoModalidade: PresencialDescrição:The full clinical affairs analyst is a skilled professional who plans, substantiates, builds and conducts a range of clinical affairs activities, including medical writing and ethical/regulatory submissions as required, in territories with similar regulatory...
-
Clinical Affairs Analyst
4 semanas atrás
são josé do rio preto, Brasil Products and Features Brasil Tempo inteiroHorário: De segunda à sexta, das 8h às 17h48 com 1h de almoçoModalidade: PresencialDescrição:The full clinical affairs analyst is a skilled professional who plans, substantiates, builds and conducts a range of clinical affairs activities, including medical writing and ethical/regulatory submissions as required, in territories with similar regulatory...
-
Clinical Affairs Analyst
4 semanas atrás
Sao Jose do Rio Preto, Brasil Products and Features Brasil Tempo inteiroHorário: De segunda à sexta, das 8h às 17h48 com 1h de almoçoModalidade: PresencialDescrição:The full clinical affairs analyst is a skilled professional who plans, substantiates, builds and conducts a range of clinical affairs activities, including medical writing and ethical/regulatory submissions as required, in territories with similar regulatory...
-
Regulatory Advisor
2 semanas atrás
Rio de Janeiro, Brasil TIM SA Tempo inteiro**Id da vaga**:22245 **Cargo**:Regulatory Advisor - Analista **Diretoria**:Regulatory,Institut. and Press Relations **Breakdown**:Regulatory Affairs **UO**:Regulatory,Institut. and Press Relations **Regional**: TIM SA Headquarter **Estado**:RIO DE JANEIRO **Cidade**:RIO DE JANEIRO **Descrição do Perfil** Responsável por suportar o desenvolvimento...
-
Clinical Affairs Analyst
4 semanas atrás
São José Do Rio Preto, Brasil Products and Features Brasil Tempo inteiroHorário: De segunda à sexta, das 8h às 17h48 com 1h de almoçoModalidade: PresencialDescrição:The full clinical affairs analyst is a skilled professional who plans, substantiates, builds and conducts a range of clinical affairs activities, including medical writing and ethical/regulatory submissions as required, in territories with similar regulatory...
-
Kafka Administrator Work for a Software Start-up ..
4 semanas atrás
Rio de Janeiro, Brasil Prometeo Talent Tempo inteiro**About us.** **Our Proposal** We're looking for a Kafka Administrator with solid understanding of Kafka architecture. The chosen person should be able to provide architectural diagrams, design documentation, standard operational procedures and other documentation on implementing and operating Kafka components. Also, to set up security on Kafka, manage...
-
Santana de Parnaíba, São Paulo, Brasil International Flavors & Fragrances Tempo inteiroJob Summarycustomers on the safe use, regulatory compliance, regulatory strategy or advocacy foringredients and products.This may include the execution of regulatory compliancereviews, the preparation of various documents supporting the regulatory compliance ofthese products or submission of registration/approval dossiers, etc.Key Responsibilities:STRATEGY &...
-
Regulatory Affairs Analyst
Há 4 dias
Região Geográfica Intermediária de Cruzeiro do Sul, Brasil PayJoy Tempo inteiroRole RequirementsTo be successful in this role, you should possess a strong understanding of data protection laws and regulatory compliance, particularly in regulated fields. You must have excellent analytical and problem-solving skills to assess risks, develop policies, and implement effective compliance programs.Key Qualifications:Proven Experience in Data...
-
Field Specialist Trainee
3 semanas atrás
Rio De Janeiro, Brasil Schlumberger Tempo inteiroThe Field Specialist Trainee is responsible for maintaining safe, efficient, and reliable PSD to Customers. The Field Specialist Trainee identifies opportunities to improve service delivery, implements standard work, and manage, risk during service delivery. - Ensure job deliverables are accurate and delivered on time. - Responsible for service delivery...
-
Compliance and Safety Specialist
Há 5 dias
Rio de Janeiro, Rio de Janeiro, Brasil Airswift Tempo inteiroCompany OverviewAirswift is a global workforce solutions provider serving the STEM industry.With over 800 employees across 60 offices globally, 7,000 contractors and a candidate database of 1.5 million specialists, our geographical reach and pool of available talent is unmatched in the industry.Job DescriptionWe are seeking a Compliance and Safety Specialist...
-
Drilling Fluids Specialist
2 semanas atrás
Rio De Janeiro, Brasil Schlumberger Tempo inteiroThe MI Drilling Fluids Specialist is responsible for maintaining safe, efficient, and reliable PSD to Customers. The MI Drilling Fluids Specialist identifies opportunities to improve service delivery, implements standard work, and manage, risk during service delivery. **Roles and Responsibilities**: - Ensure job deliverables are accurate and delivered on...
-
Clinical Trial Coordinator
Há 8 horas
Rio de Janeiro, Rio de Janeiro, Brasil Thermo Fisher Scientific Tempo inteiroWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionPurpose:Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation...