Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.
Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAA, NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
Support Regulatory Affairs personnel in the coordination, preparation, and submission of all above submissions.
Responsible for the pre-publishing (Bookmarks and Hyperlinks), compilation, post publishing, Validation of Regulatory submissions and lifecycle management submissions.
Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats.
Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into electronic document management system) within specified time frames.
Liaise with functional source areas (clinical, nonclinical, CMC, regulatory) to ensure documents are compliant with authoring style guide. “Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications”.
Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the US FDA, EMEA and ICH.
Establishes relationships with customers; may meet rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.
May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
May represent on project team meetings, driving timelines and deliverables related to submission documents. Present to Customers on periodic status of the projects.
Acts as an SME/ expert in Regulatory knowledge in Publishing as applicable. May act as reviewer for regulatory SOPs, as assigned and appropriate.
Technical knowledge of electronic publishing systems and software (Veeva Vault, RIM Smart, Insight, eCTDXpress, Extedo, Lorenz).
Proficiency with MS-Office Suite and Adobe Acrobat applications, Knowledge of Veeva system.
Self-starter with superior time management skills, and ability to work independently or in teams.
Performs other tasks or assignments, as delegated by Regulatory management.
Knowledge of eCTD Submission publishing principles (US and EU (mandatory)), and concepts of a job area, typically obtained through advanced education combined with experience.
Good understanding of the Regulatory Submissions guidelines, experience with ICH submission ready standards.
Good, solid interpersonal communication (oral and written) and organization skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Ability to make decisions on discrete tasks under senior supervision
Ability to work on several projects, with direction from senior staff as appropriate
Bachelor's Degree in Life science or related discipline OR Master's Degree in Life Science or related discipline
Minimum of 5-6 years of prior relevant experience.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.