Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs.
RESPONSIBILITIES
* Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer.
* Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
* Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications.
* May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs.
* May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs).
* Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
* Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
* Deliver regulatory training/presentations as required, internally or externally.
* May mentor junior colleagues and engage in department knowledge sharing.
* 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.
* Demonstrates comprehensive regulatory/technical expertise.
* Good negotiating skills and the ability to identify and resolve issues, using a flexible adaptable approach.
* Strong ownership and oversight skills.
* Demonstrated skills in chairing meetings and working on initiatives.
* Ability to work on several projects, retaining quality and timelines and can prioritize workload.
* Ability to propose revisions to SOPs or suggest process improvements for consideration.
* Strong mentoring skills, helping junior colleagues and setting a positive example.
* Innovative and solutions-driven.
* Strong skills in establishing and maintaining effective working relationships with co-workers, managers and clients.
* Strong software and computer skills, including MS Office applications.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience).
* EU-CTR knowledge & experience.
* Global CTA submission experience.
PHYSICAL REQUIREMENTS
* Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
* Extensive use of keyboard requiring repetitive motion of fingers.
* Regular sitting for extended periods of time.
* Travel might be required.
This role is not available for UK visa sponsorship.
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