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The** **Country Site Activation team is aiming to identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication.By joining us as a **Regulatory Services Imports Specialist in FSP **(Functional Services Partnership)**, **you will perform tasks at a country level associated with Study Start Up contracts, such as developing the global contracting strategy and support the delivery of all required start-up contracting activities as determined by the client requirements.**Your responsibilities will include**:- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.- Perform start up and site activation import activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.- Prepare site import documents, reviewing for completeness and accuracy.- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.- Review and provide feedback to management on imports performance metrics.- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.- Inform team members of completion of regulatory and contractual import documents for individual sites.- Perform quality control of documents provided by sites.- May have direct contact with sponsors on specific initiatives.**Qualifications**:**Minimal requirements**- Bachelor’s Degree in Life Science or related field- At least 1-2 yrs experience in Regulatory and Start up Imports area or similar (or equivalent combination of education, training and clinical, healthcare and/or pharma experience)- Fluent language capabilities, including English.**Skills**:- Ability to work independently to problem-solve collaboratively and to raise issues appropriately as needed- Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors- Ability to handle change and ambiguity- Ability to work on multiple projects- Knowledge of clinical trial environment and drug development process advantageous**What you can expect**:- Consistent career growth.- Leaders that support flexible work schedules.- Programs to help you build your therapeutic knowledge.- Dynamic work environment that exposes you to new experiences.- Attractive benefits package.**Work conditions**- Home based role.- Grade 140 (Sr. role)**#LI-Remote #LI-RUBENALEJOS
