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Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
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Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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Alongside clinical research through our PPD clinical research portfolio, our work in evidence-based solutions specializes in generatingthe evidence needed to optimize the commercial potential of our biopharma and biotech customers products.
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Additionally, the role will coordinate and support inspection management activities for global health authority inspections of PPD. Support manager and others within Regulatory Inspection and Client Audits (RICA) department to host and/or coordination of HA Inspections at PPD and all related activities.
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Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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At Thermo Fisher Scientific, youll discover meaningful work that makes a positive impact on a global scale. Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.
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Strong presentation skills and proven ability to represent the department PPD values the health and wellbeing of our employees. Manages full supply chain oversight for high complex global clinical trials.
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Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to relevant legislation/regulations/guidance, global SOPs and client expectations. Broad understanding of PV along with working knowledge of the global regulatory requirements and the importance of procedural/process compliance.
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Validated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) May lead or help to enhance the department's performance or lead to process improvement across PPD. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.
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We are currently seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs department Regulatory Science team. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance.
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Lead the global marketing strategy for the assay segment of Protein Leadership within the Protein Diagnostics Division (PDX) of Thermofisher, driving earlier diagnosis and business growth. Oversee a team of 8 upstream and downstream marketers, collaborating with both R&D & Commercial to ensure seamless global execution.
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Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely manner Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
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Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. We are prioritizing candidates with cell therapy and or gene therapy experience as a CRA.
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Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents. Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor.
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