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. What the Regulatory Affairs Specialist does at Worldwide
Be a subject matter expert and primary contact for activities supporting Regulatory Authority submissions in coordination with Site Activation & Regulatory (SAR) colleagues for awarded projects. Responsible for leading the planning, initiating, and tracking documents required for regulatory submissions and communicating status, risks and actions related to project regulatory activities. May act in a support role to local CRA with regulatory activities when a dedicated regulatory resource is not present locally. Reports to the Site Activation and Regulatory Lead. What you will do
Liaise with SAR colleagues to drive plan, organize, compile, progress, track and submit regulatory submissions on a timely basis and with a consistently high level of quality. May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc. Maintain country specific patient information sheet and consent form customization text, maintain country specific drug labeling information and Country Intelligence Pages. Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements.
What you will bring to the role
Organizational and time management skills. Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills. Strong written and verbal communication skills to clearly and concisely present information in English and local language. Strong ability to handle multiple tasks in a fast-paced and changing environment. Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint. Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
Your experience
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science. Minimum two years of experience in clinical research, preferably in site activation and/or regulatory-related function. Previous experience within the pharmaceutical/CRO industry. Thorough knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance. Multilingualism preferred; fluent in local language; working knowledge of English.
Why Worldwide
We love knowing that someone is going to have a better life because of the work we do. #J-18808-Ljbffr
