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Wszystkie (13)Aktualne ( 0 )Archiwalne ( 13 )
Specjalista / Specjalistka ds. regulacji terenowo-prawnych
Marszałkowska 142, Śródmieście, Warszawa
Wygasła: 07.05.2023
full-time
umowa o pracę
hybrid work
specialist (Mid / Regular)
Obowiązki:
Job summary:
As a Regulatory Specialist you will be expected to provide clerical support to project team during the study conduct, assist in regulatory submission and Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management. We are searching for a positive and energetic person, eager to learn, push forward administrative processing of the documents and function well in the project team. The suitable candidate shall have desire to develop in Regulatory activities and specialise with the time in Regulatory submissions and requirements for Poland
Main Tasks of the Position:
- Participates in all activities that lead to start up of investigational sites
- Takes part in the communication with Regulatory Authorities and Ethics Committees
- Interacts with Customers when receiving requirements from Regulatory Authorities
- Provides interpretative assistance of guidance documents and regulatory rules and ensures their communication through company policies and procedures
- Provides training and support to CRAs in order to collect all necessary documents for start up package and IP release
- Close collaboration with Regulatory Lead and Project Team during entire project
- Performs tasks according to relevant SOPs and completes the SOPs training in given timelines
As an HR Generalist you will be expected to assist an established HR department with daily tasks to ensure smooth business operations. The diversity of responsibilities is vast with focus on recruitment and talent acquisition. A much-needed support to senior HR management, HR generalist is relied on for his/her detail-oriented and interpersonal skill to help administer various HR initiatives for internal and external personnel. You will provide operational management of various recruitment processes within the company and will also act as the main point of contact for employees’ queries on HR-related topics
The goal is to ensure the HR department’s operations will be running smoothly and effectively to deliver maximum value to the organization as a whole
Reporting to Head, Human Resources, you will be a key member of the HR team companywide. We are searching for an experienced, ambitious and energetic person, with strong people knowledge and experience and significant negotiation skills. The desired person shall be open to cross cultures communication and cooperation and shall be independent in their performance
Main Tasks of the Position:
- Performs routine tasks required to administer and execute human resource programs including but not limited to compensation, benefits, and leave; disciplinary matters; disputes and investigations; performance and talent management; productivity, recognition, and morale; occupational health and safety; and training and development
- Manages talent acquisition and recruitment processes
- Handles administrative tasks for onboarding, new hire orientation, and HR system maintenance for assigned countries
- Handles employment-related inquiries from applicants, employees, and supervisors, referring complex and/or sensitive matters to the appropriate staff in assigned offices
- Attends and participates in employee disciplinary meetings, terminations, and investigations
- Promotes HR programs to create an efficient and conflict-free workplace
- Assists in development and implementation of human resource policies and contributes to corporate policy development
- Undertakes tasks around performance management
- Maintains employees’ files and records in electronic and paper form including Personal files database (CV, JD, PTL, Certificates) of the assigned teams
- Gathers and analyzes data with useful HR metrics and maintains company’s charts, reports and databases
- Keeps up to date knowledge and know how about local teams members, teams processes, labor code and legal requirements in the assigned countries/ teams
Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law
- Enhance job satisfaction by resolving issues promptly, applying new perks and benefits and organizing team building activities
- Completes other tasks if assigned and necessary
Please, submit your application to the following link: https://easthorn.bamboohr.com/careers/73
As a Clinical Project Administrator you will be expected to provide clerical support to project team during the study conduct, assist in regulatory submission and Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management
Reporting to the Clinical Project Lead, you will be an important member of the Clinical
Operations team in Poland
We are searching for an ambitious and energetic person, able to undertake challenges in the projects
We ensure detailed training in the job responsibilities and on the job support and mentoring as well as possibility for further development and career advancement in our growing company
Main Tasks of the Position:
- Providing clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
- Assisting in submission and other Clinical Research Associate activities e.g. compiling
of regulatory packages, translation of clinical documents, updating trackers, assisting in feasibility
- Setting up and maintaining clinical investigator files and documentation in-house and on-site
- Preparing investigator budget payments and tracking systems; generating tracking reports as assigned
- Performing data entry and maintenance of selected study tracking databases
- Preparing monitoring visit documentation for Clinical Research Associate
- Preparing study-related documents and other materials for delivery to archives, at appropriate intervals
As a Regulatory Specialist you will be expected to provide clerical support to project team during the study conduct, assist in regulatory submission and Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management. We are searching for a positive and energetic person, eager to learn, push forward administrative processing of the documents
and function well in the project team. The suitable candidate shall have desire to develop in Regulatory activities and specialise with the time in Regulatory submissions and requirements for Poland
Main Tasks of the Position:
• Participates in all activities that lead to start up of investigational sites
• Takes part in the communication with Regulatory Authorities and Ethics Committees
• Interacts with Customers when receiving requirements from Regulatory Authorities
• Provides interpretative assistance of guidance documents and regulatory rules and
ensures their communication through company policies and procedures
• Provides training and support to CRAs in order to collect all necessarily documents
for start up package and IP release
• Close collaboration with Regulatory Lead and Project Team during entire project
• Performs tasks according to relevant SOPs and completes the SOPs training in given