Medical Operations Specialist (Buenos Aires)

AbbVie Ver todas las vacantes

  • Buenos Aires
  • Permanente
  • Tiempo completo
  • Hace 15 horas
Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world.We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients' lives around the world. In short, we know it takes you make those groundbreaking advancements happen.**Main Responsabilities**:- Prepares CA (Competent Authority) and/or EC (Ethic Committee) documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
- Customize and execute agreements, consent and assent forms, local monitoring plan and other documents for evidence generation projects. Participate in the development of protocol and synopsis for evidence generation projects. Actively participate in the amendment of all the required documents of evidence generation projects.
- Identify, evaluate and recommend new/potential investigators/sites on an ongoing basis.
- Participate in the selection process of investigation sites and principal investigators, ensuring the engagement of physicians and institutions of high scientific relevance and in accordance with the corporate strategy.
- Lead the process of scientific publications in the affiliate. Initiate, monitor and manage affiliate publication activities and oversight of publication management e.g., planning (annual publication plan) including budget planning tracking of publication activities and reviewing publication plan regularly by publication lead.
- Identify, evaluate, and recommend new/potential medical writing and CRO vendors on an on-going basis.
- Manage the development of scientific publications: results of local studies, sub-analyses of integral studies, pharmacoeconomic studies, database analysis, bibliographic reviews, and others.
- Ensure the operational support to the "Publication Lead" of the entire internal and external process for the execution of the publications. Ensure that all affiliate "Publication Leads" receive the required training.
- Identify and address affiliate publication projects issues, with elevation to ensure resolution if appropriate. Minimize any potential publication process deviations. Ensure that local scientific publications are developed in accordance with AbbVie policies.
- Ensure that external authors have authorship criteria to manage so that publication-related activities are carried out in compliance with AbbVie's policies.
- Ensure the dissemination of locally generated evidence.**Qualifications**:- Education: Complete higher education, preferably in the health area, or equivalent combination of education, training and experience
- Computer and software knowledge like MS Office (Word, Excel, PowerPoint, Outlook)
- Advanced knowledge of Clinical Study Management and in Scientific Publishing
- Desirable knowledge in Clinical Research, Pharmacoeconomics, Pharmacovigilance, Quality, Financial Management
- Experience working in pharmaceutical industry (advantage).
- Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be an advantage.
- English language management verbally and in writing

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