Specialist, Regulatory Compliance

Who We Are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
Responsibilities

• Receive, review, process and file essential documents, part of the Essential Document (ED) package agreed for the study, in accordance with applicable local regulations, internal SOPs and guidelines and ED Review Plan.
• Check the completeness of the ED packages as well as the quality of the documents provided
• Communicate corrective action and ensure issue resolution to meet documentation requirements as required, prior to approval of the ED packages and ED checklist sign off.
• Complete/updated relevant tracking tool on ongoing basis to allow visibility to project teams on the ED review progress status.
  

Other Skills And Abilities

• English written and spoken, advanced level
• Strong organizational and time management skills
• Exercise sound judgment and ability to identify decisions requiring supervisory approval
• Handle multiple tasks with exceptional accuracy
• Computer literacy in Microsoft Word and Excel
  

Requirements

• University degree preferred (Life Science desirable) and 2 year of relevant experience or
• Combination of education and 3 years of relevant experience
  

We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.