Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Primary Function of Position:
The principal purpose of this job function is to provide support for Clinical Affairs (CA) project documentation and operational support. In addition, to provide administrative support to the CA team in daily business activities.
This position is based at the Intuitive Surgical EMEIA Head Office in Switzerland.
Roles and Responsibilities:
- Take part in preparation and tracking of research budgets, payments and documentation and provision of updates to the finance department.
- Establishes, organizes, and maintains study files (paper and electronic) including but not limited to, regulatory binders’ content, study specific source documentation, contracts, payments etc. and other materials.
- Support preparation of study-related documentation such as protocol worksheet, procedure manuals, and progress reports.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Support project managers on adverse event reporting Develop advertising and other informational materials to be used in subject recruitment.
- Check CA activities comply with IS quality system and raise opportunities for improvements in process.
- Participate in quality assurance audits conducted by study sponsors and regulatory agencies.
- Responsible for drafting and tracking of CA contracts and NDAs.
- Maintain documentation of CA training outside ISU.
- Manage CA meeting arrangement support e.g., internal meetings and advisory boards, including all logistic arrangements and consolidation of materials.
- Support literature requests for all relevant departments.
- Attend conferences and seminars to maintain current knowledge of CA regulations, laws, and best practice.
- Responsible for maintenance of EU CA project tracking, intranet page and CA newsletter.
- Administrative support for the CA team.
Required Knowledge, Skills, and Experience:
- At least 1 year experience within a Clinical Affairs role.
- Previous similar administrative experience 2-3 years minimum.
- Minimal travel - arrangement of meetings, travel accommodation, facilities, materials.
- Excellent communication, written and oral interpersonal skills with high attention to detail.
- Demonstrated superior ability to organize, prioritize and manage multiple tasks simultaneously.
- Flexible and reliable.
- MS Office proficient, Excel, Word, Outlook, PowerPoint.
- Fluent at least in English and French.
Preferred Knowledge, Skills, and Experience:
- BS in Life Sciences or documentation management.
- Fluent in other EU languages.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.