Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. 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. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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We are currently seeking a Senior Regulatory Affairs Specialist to join our RCR (Regulatory Compliance Review) team. You will have the unique chance to join a global team whose primary function is the review and approval of essential documents. You will provide key support with investigational product and substantial review of documents so that the medicinal products can be shipped and the clinical sites can be activated.
This is a fantastic opportunity to further your regulatory career and develop your expertise in this field!
Senior RCR Specialist, Regulatory Compliance Review, Regulatory Affairs
Major responsibilities:
• Perform global regulatory compliance review of essential documents supporting the start of clinical studies
• Respond to RCR reviewers/submitters on queries on essential documents
• Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams
• Ensure effective management and coordination of the Regulatory Compliance Review Process
• Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
• Responsible for tracking RCR approvals
• Responsible for updating and posting of the RCR Compliance Review list as well as forms and posting on the RCR home page
• Assist in development and validation of country-specific review forms for new countries, revision, and validation of existing review forms as necessary
• Assist in the organization of the training of RCR reviewers, when required
• Assist in development and tracking of RCR metrics
• Where required/applicable, assist in project specific RCR processes and training of the RCR reviewers' group
• Other duties as required
What we offer:
At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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