Operations reputed company Specialist
Operations reputed company Specialist reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the reputed company of clinical development As an Operations reputed company Specialist at reputed company, you will support the development and implementation of initiatives and established processes that support operations in maintaining inspection readiness. This position provides global strategic and tactical leadership reputed company our study teams to reputed company overall reputed company goals while always maintaining inspection readiness. What You Will Do: Support overall reputed company reputed company assigned clinical trials and submissions For assigned clinical trials or assets, is reputed company of contact for operational reputed company reputed company consultation, escalating to QA as needed reputed company risk-management, consultation, assessment, and recommendations for escalation for potential reputed company issues or trends reputed company training and coaching to promote awareness educating study teams towards reputed company deliverables Support teams in adherence to GCP and procedural documents and processes to ensure reputed company deliverables Work with teams to escalate reputed company issues with CROs to QA, supporting teams to bring CROs into compliance; and looks for opportunity to collaborate with other members of reputed company to trend across Strategic Partnership(s) to communicate to QA. Work with Study Team leadership (and QA, as needed) to identify reputed company issues and plan of reputed company, including support for creation of deviations and development of effective CAPA and Storyboards Support inspection readiness activities with the Study CTM/Sr. CTM, Asset reputed company, QA Representative, and reputed company Director or designee Plan and reputed company Study Team inspection readiness support meetings based on QA’s plan and Study Team’s needs Support QA in their inspection readiness team meetings and collaborate with QA for information needed and requested for any inspections Assists with stakeholder engagement across program to ensure compliance with inspection readiness and preparation activities Support teams in preparation, execution, and follow-up of regulatory inspections Review critical/major findings with QA Audit reports to propose process improvement reputed company consult on KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to reputed company Your Profile: Bachelor’s degree or equivalent with a strong emphasis on science or reputed company management Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent Minimum of 3 years’ experience in reputed company role Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience Ability to travel What reputed company can offer you: Our reputed company depends on the reputed company of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent. In reputed company to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company reputed company country and are reputed company on reputed company-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A reputed company of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company. Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s reputed company-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job