BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement: Fluent English Required Preferred
Experience
Pharmaceutical/Biotech Industry, Hematology, Oncology Location: Sao Paulo Hybrid General Description: Support in the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne SOPs, and local regulations.
Essential Functions
Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs Site Feasibility Build knowledge in therapeutic area, local regulations and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI. Site Start-Up Skilled in driving kick-off and completion of tasks from selection through activation. Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible. Prepare submissions dossiers to Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs and work instructions. Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. ICF/Submissions Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out. Skilled in document preparation and submission to IRB to ensure timely reviews. Support review of essential documents Provide Regulatory support after approvals, including submission of core documents to the sites and Regulatory Authority, and Annual/Final reports to Regulatory Authority. Complete SSU data entry in CTMS, if applicable Support in the development of local workflows to streamline output and deliverables. Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals. Perform the translation process for ethical and regulatory documents Minimum
Requirements
–
Education
and
Experience
Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 1 year of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment. Other
Experience
Knowledge in the execution of clinical trials, understanding of ICH/GCP Prioritization of tasks in the achievement of goals Strong written and verbal communication skills Highly organized Diligence in follow through Supervisory
Responsibilities
N/A Travel: Up to 10% Computer Skills: Intermediate skills in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams #LI-Remote Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit