Trainee - Regulatory Operations (Publishing)

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Operations Trainee on a permanent basis. You will work on projects from our varied client base,...

Provides publishing support for regulatory submissions within the life sciences industry. Includes document level and submission level publishing, archive activities, report publishing, general PDF navigation, conversion of paper documents to electronic format, and paper submissions. - Supports electronic communication and submission processes including...

Regulatory Affairs Professional Job DescriptionOur team seeks a skilled Regulatory Affairs Associate Senior to lead the publishing and dispatch of regulatory submissions for Devices & Drugs Submissions. Key responsibilities include:Managing and leading regulatory publishing operations globally.Ensuring submissions meet eCTD requirements and other regional...

Regulatory Operations Associate - Home based - Bengaluru/ Chennai/ Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

**Position Summary**: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA,...

Key Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...

**RESPONSIBLITIES**: - To own the P&L from the publisher monetization function - On-board new publishers and manage the publisher network. - Analyse inventory yield and optimize to deliver better yield. - Acquiring Demand partners. Build a robust demand ecosystem. - To own the Publisher client relationship as the face of Datawrkz. - Improve Publisher...

**Department-** Clinical Reporting, GD-GBS **The Position**: Clinical Publisher will be responsible for Compilation and publishing of clinical documents including but not limited to Clinical Trial Reports (CTRs), Investigator’s Brochures (IB), Non-intervention Study Reports (NSRs), Clinical summaries and overviews, lay summaries etc. Plan and coordinate...

**About the Role** As a **Business Operations Trainee** at our EdTech company, you will have the opportunity to immerse yourself in the dynamic world of education technology. You will support day-to-day operational functions, help streamline processes, and work closely with various departments to ensure efficient delivery of our educational services. This...