Clinical Trials Regulatory Officer

IQVIA (Buenos Aires, Argentina) Seguir Publicado hace 11 horas

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PURPOSE

Prepares and/or reviews regulatory documents to support clinical trial submissions. With guidance from senior staff, provides regulatory support for more complex projects.

RESPONSIBILITIES

Acts as a Clinical Trial Regulatory Manager (CTRM) on straightforward projects independently and complex regulatory projects under the guidance of senior staff.

Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.

Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.

Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.

· May strategically plan and perform/support European centralized submissions and facilitate global submissions with minimal supervision

·Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.

·Ensures high quality in all regulatory deliverables

·Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).

· Ability to participate in audits relating to Projects and Systems.

· May perform additional tasks as deemed appropriate by Line Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Good understanding of the regulations, directives and guidance supporting clinical Research and Development
Extensive experience in regulatory and/or technical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Strong ownership and oversight skills
Ability to earn respect from peers in other operational groups
Advanced ability in establishing and maintaining effective working relationships with co-workers, managers and clients
Innovative and solutions-driven
Strong software and computer skills, including MS Office applications
Sets a positive example to more junior colleagues relating to a professional manner, positive attitude and communication style with customers and colleagues
May take calculated risks when making decisions, seeking guidance from Regulatory management, as appropriate; demonstrates autonomy and initiative, as appropriate

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in life science-related discipline or professional equivalent plus at least 6 years relevant experience* including 3 years in regulatory experience.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com