Company: Novella Clinical Resourcing
Reference: NCI_Snr Reg Associate_UK_Contract/Perm 3201
Closing Date: 28 Dec 16
Type: Full Time
Salary (£): 30,000 - 40,000
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 Senior Regulatory Associate 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. Whilst we recruit for this permanent position we are also looking for temporary contract cover
To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Regulatory Affairs Manager (currently US only) and Director of Regulatory Affairs 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.
· Assist Regulatory Affairs Manager and Director of 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.
· Support regulatory documentation review related to the compilation and maintenance of project specific master files as 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 Ethic Committees and competent authorities as delegated by Novella Sponsors.
· Review all essential regulatory documentation both for Green light release and ongoing throughout the life cycle of the study.
· Support project teams with review of essential documents and country regulatory documentations are audit ready at all times.
· 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 UK Statutory instruments, EU Directive, Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice., ISO standards and all regulatory requirements of EU countries.
· Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
· Familiarity with or ability to assist 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.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
· Ability to travel domestically
· Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
· Requires Bachelor's degree with at least 1 year of related work experience, science degree preferred or equivalent level of education and work experience.
· Six months to one year 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.
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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