Senior Specialist, Regulatory & Site Activation - Chile - Remote (Bío Bío)

OverviewSenior Specialist, Regulatory & Site Activation - Chile - RemoteWorldwide Clinical Trials is a general, midsize CRO with a mission to improve lives through quality and excellence. We are a diverse, inclusive team of more than 3,500 experts dedicated to advancing the drug-development process for patients and their caregivers.We are an equal opportunity employer committed to cultivating an inclusive environment that supports collaboration and creativity. All applicants will be considered for employment without regard to race, color, religion, sex, national origin, disability, or any other status protected by applicable law.What You Will DoLiaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis with a consistently high level of quality.May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, 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) to comply with ICH GCP and country-specific requirements.Your ExperienceA minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or related science.Minimum three years of experience in clinical research, preferably in site activation and / or regulatory-related functions.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.What You Will Bring To The RoleOrganizational and time-management skillsAbility to plan, strategize, manage, monitor, schedule, and critique workStrong written and verbal communication skills in English and local languageAbility to handle multiple tasks in a fast-paced, changing environmentProficiency in MS Office (Word, Excel, PowerPoint)Understanding of country-level cultural norms and local healthcare systems; ability to develop relationships with local investigators and key site personnelSeniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalIndustriesResearch Services #J-

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