Pharma Regulatory Dossier Publisher
Softenger Singapore Pte Ltd
jobsDB ref: JSG400003003032691
EA License No. 13C6584
Permanent position with leading MNC.
PFB JD as follows:
- Responsible for global regulatory submission / dossier publisher day-to-day activities and deliverables. Regulatory Publishing involves preparing the Clinical Documents (written by the Med. Writers) for submission through eCTD.
- Experience with electronic document management systems, publishing tools, basic knowledge of documents publishing/document management including, Adobe Acrobat.
- Compilation of regulatory documents, Maintaining Regulatory documents as per the procedure in client repository.
- Performing high level of formatting in both word and PDF files using the client provided software. Creating Bookmarks, hyperlinks, file Optimization etc. are some of the key activities.
- Perform technical quality control (electronic functionality, adherence to internal and external document standards) of dossier documents.
- To interact with scientific personnel and Project Team Representatives in the preparation, QC and publishing of nonclinical and clinical study reports and regulatory documents.
- Provide input and advice to project and trial teams on “submission readiness” requirements for document components.
- Supporting the client in aligning the process maps/SOPs/WI as per recent updates.
- 3-5 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (US, EU, Asia, Latin America, etc).
- Expert in HA submission publishing requirements globally.
- Strong knowledge, of Regulatory processes and related tools (document management, publishing, etc.
- Excellent verbal and written communication skills.
- Demonstrated ability to be innovative and a creative thinker
- High level of organizational awareness.
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About Softenger Singapore Pte Ltd
Softenger offers a variety of managed services in the field of Information Technology. We are committed to provide the right services to maintain and enhance your IT infrastructure, so that you can focus on achieving your business vision. Ideas are the foundation of evolution. There must be a drive to act on those ideas. Our services start with precision thinking, followed by focused approach and proficient execution. Softenger provides your business with a broad array of Enterprise system management services based on Industry-standard methodologies and practices. From system, database administration to Security Solutions and continuity of business, we deliver services that will meet your business strategies and goals.