Hybrid Submission Publisher Consultant bei Clinchoice

  Submission Publisher

Responsibilities:

• Support regulatory activities for products and marketed product maintenance related to the The product lines include drugs, devices, cosmetics, and other consumer products
• Compile electronic- or paper-based-submissions necessary to meet regulatory requirements using available electronic publishing tools
• Dispatch electronic submissions through health authority portals
• Work with project teams and regulatory project leads to prioritize submission-related activities to deliver contributory submission documents within established timelines
• Provide support for data entry, maintenance, and retrieval from computer-based information systems
• Disseminate current information related to electronic document management and publishing, to colleagues within the R&D Consumer organization, and in addition provide them with support, training, and coaching in regard to the appropriate use of electronic information systems relevant R&D documentation
• Responsibilities will also include interaction with the regulatory liaisons with specific product responsibilities, document contributors, and IT System Liaisons within the global R& D organization
• Typical systems that would be used include but are not limited to – Documentum / Connect, docuBRIDGE, Insight Publisher, eValidator, and applicable file-share systems 

Deliverables:

• Electronic or paper regulatory submission for the regions.
• Current information on electronic document management and publishing to CLIENT’s Regulatory associates
• Training and support to RDO on the appropriate use of electronic information systems for relevant R&D documentation
• Provide support for data entry, maintenance, and retrieval from computer-based information systems
• Periodic metrics decks and meetings to evaluate publishing performance

Experience/Qualifications:

• Educational Requirements: minimum bachelor’s degree in science
• Minimum Experience Required: minimum 1 year of experience in the life-sciences industry, preferably in a publishing role
• Experience with a variety of computer software and systems. Familiarity with publishing tools preferred
• Demonstrate excellent communication skills (English language) – both oral and written
• Well-organized and detail-oriented