Regulatory Specialist (Italy - Home Based) - Novella Clinical
Novella focuses on providing excellent training and career development opportunities, encouraging growth from within our talented work force. Novella specialises in leveraging technology and Clinical Research and continues to improve the quality and service across a broad range of therapeutic areas including Oncology and Medical Devices. Our parent company is one of the World’s leading not profit research organisations, and you will be joining a passionate and motivated team.
Novella Clinical is one of the few companies that continues to experience a sustained growth through the recent economic challenges, investing at all levels including infrastructure. We are also proud of being one of the very few global CROs to work to the high standards of ISO accreditation.
We have a Regulatory Specialist opening, to provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies).
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
- Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
- Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.
- Serve as Novella liaison with central IRBs.
- Perform other related duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
- Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
- Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
- Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
- Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.
MINIMUM RECRUITMENT STANDARDS:
- Requires Bachelor’s degree with at least 3 years of related work experience, science degree preferred or equivalent level of education and work experience.
- Two or more years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research.
- Excellent analytical and communication skills, particularly writing skills, are essential.
- Demonstrated computer literacy is required.
- Ability to travel a minimum of 20% both domestically and internationally is required.
For further information contact Sue Spice on 01438 794518
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