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Specialist/Lead - Publishing at ClinChoice

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Electronic Publishing, Regulatory Requirements, Data Entry, Information Systems, ISI Toolbox, Bookmarks, Hyperlinks, PDF Editing, Validation, Troubleshooting, Communication Skills, Regulatory Updates, Team Guidance, Mentoring

Industry

Pharmaceutical Manufacturing

Description

Primary Responsibilities: • Compile electronic- or paper-based-submissions necessary to meet regulatory requirements using available electronic publishing tools such as Docubridge/Insight Publisher/EXTEDO for EMA US markets and ROW. • Dispatch electronic submissions through health authority portals. • Provide support for data entry, maintenance and retrieval from computer-based information systems. • Knowledge on using ISI Toolbox to create Bookmarks, Hyperlinks and to edit PDF documents. • Validating published outputs and troubleshoot if there are any warnings or errors. • Good communication skills required to communicate with client on day to day basis. • Good hold on latest regulatory updates. • Guide and mentor a team of junior associates

Responsibilities

The specialist/lead will compile electronic or paper-based submissions to meet regulatory requirements and dispatch electronic submissions through health authority portals. They will also validate published outputs and provide support for data entry and information systems.