MARKETING INTERN – LATAM
São Paulo - SP - 3 times at Vila Olimpia
Who We Are
Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science when it comes to solving the challenges of our clients' projects in a focused and exclusive fashion.
Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.
Basic Functions and Responsibilities includes, but are not limited to:
▪ Study supplies (Investigational Product (IP), Devices, and Clinical Trials Materials, laboratory samples, among others): Importation, Exportation, Storage, Shipment, Purchase, Return, Destruction;
▪ Support to develop tools and processes for LATAM countries for logistics;
▪ Following the Intrials SOPs, sponsor’s needs, local regulations, and Good Clinical Practices (ICH-GCP);
▪ Act as legal representative before the regulatory bodies or for customs clearance;
▪ Work closely with Project Manager (PM) or Reg Lead to define importation strategies for assigned studies, to review, track and follow up the progress, provide support on the metrics and KPIs for the logistic área.
▪ Sites, sponsors, brokers, and regulatory agencies contact to obtain documentation required for import process of clinical studies in LATAM;
▪ Management local depot in LATAM, with follow up of deliverables;
▪ Might manage LATAM countries logistic deliverables and activities during start-up and maintenance with close communication with internal team, sponsor, sites and vendors. ▪ Study dossiers (import/export) preparation and review for the submission to regulatory bodies;
▪ Regulatory status follow-up along with sites and regulatory agencies, to obtain submission, pending or approval letters (import / export). Responsible for keeping the status tracking with the provided information for sponsor reporting purposes;
▪ Study supplies management assistance, ensuring the quality of storage, sites shipment, return and destruction;
▪ Assist the Regulatory Coordinator in the administrative tasks related to studies under his/her responsibilities, in relation to logistics planning and conduction in accordance to GCP-ICH, LATAM regulatory requirements and SOP standards;
▪ Assist in the revision of the SOPs related to the department activities;
▪ Assist in the logistics trainings to Intrials LATAM team and communicate with Latin America team (collection of docs, information, guidelines on regulations, etc);
▪ Participate in local meetings/courses, aiming to improve knowledge.
Requirements:
▪ University degree in any career related to importation / logistics area (Administration, Foreign trade, health area, etc);
▪ Minimum of 2-3 years of experience working in logistics area in pharmaceutical companies, clinical sites, couriers, local depot or CROs;
▪ Advanced knowledge of local regulations;
▪ Intermediate planning skills for time, scope, quality, budget management for studies under coordinator supervision;
▪ Deep knowledge of Office software and Adobe Acrobat software;
▪ Advanced knowledge of oral and written in English;
▪ Individual must be multi-task oriented, with great planning, interpersonal and communication skills;
▪ Organized, strong attention to detail, great technical knowledge.