Job Overview
Supports peer Publishers/Publishing Leads and eCTD Lead in the preparation of study reports, submissions, or other documents for either internal IQVIA customers or external clients by providing quality control review, collecting appendices for documents, document preparation and publishing, and providing general assistance with document compilation.
Responsibilities:
- Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.
- Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including 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.
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
- Perform QC process to ensure the integrity and quality of each published unit.
- 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.
- May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
- Keep close interaction with authoring community to track availability of deliverables.
- Technical knowledge of electronic publishing systems and software (Veeva Vault, RIM Smart, Insight, eCTDXpress, Extedo, Lorenz)
- May prepare and deliver trainings, as appropriate.
- Proficiency with MS-Office Suite and Adobe Acrobat applications, Knowledge of Electronic Document Management Systems.
- Responsible in solving day to day queries of the team members.
- 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.
Qualifications :
- Bachelor’s degree in a life science-related discipline, preferred understanding of Regulatory Affairs in general, Publishing with 3 to 7 years of industry experience.
- Basic knowledge of clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs) or the ability and willingness to gain this knowledge.
- Strong communication skills (verbal, written and aural).
- Strong organizational skills and time management skills.
- Proficient in Microsoft office and web-based applications.
- Attentiveness to detail and accuracy; ability to maintain quality standards.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Proven ability to multi-task, manage competing priorities and deadlines.
- Willingness and aptitude to learn new skills.
- Self-motivated and flexible.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.