Document Publishing & Redaction-Scientific Writing & Communications

Key Responsibilities:

1) Productivity and Efficiency

• Perform document specialist/ CME activities like data QCs, formatting QCs of various medical writing documents, pre-publishing, publishing, appendices collation and transparency deliverables like redaction,data annonymization, QCs of lay summaries etc. in accordance with documented guidelines, SOPs, and timelines.
• Format all documents to ensure compatibility with requirements for electronic publishing and submission to regulatory agencies

• Good knowledge about ISI toolbox, document management systems

• Effective project management and optimal project utilization: ensuring maximum productivity per assigned workload and defined metrics

2) Compliance to timeliness, quality, processes & policies

• Achieve high quality deliverables with minimal oversight and robust review process including addressal/rationalisation of all review comments

• Ensure that documents are approved and issued as per timelines and comply with established quality standards and performance metrics

• Strict adherence to applicable processes and policies, including but not limited to applicable regulations, guidelines, policies, SOPs, WIs, process flows, templates, style guides, etc

• Ensure timely reporting of deliverables, project updates & prompt issue escalation to the line manager/

project manager; perform any other responsibility assigned by Line Manager

• Timely and regular update of all tools and trackers; documentation and archival of deliverables; be prepared for any audits and inspections

3) Support new and existing business

• Help diversify business by supporting strategies and business development efforts

• Support department promotional activities assigned by reporting manager/ business leads

• Be prepared for any audits and inspections with maintaining all systems and processes up to date.

4) Talent Management:

• Work effectively with other writers, communicating project information in a timely manner

• Effectively contribute in imparting trainings, process improvements, lesson’s learnt and knowledge sharing sessions

• Ensure business continuity with minimal or no dependency on self