Job Description

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Ensure timely delivery of error-free, high-quality CMC documents that meet international standards of written English by:

• Correcting errors in grammar, style, and syntax. Ensuring accuracy of the data and content presented by cross checking with the source documents. Identifying and fixing flaws in logic and flow
• Following style guides/templates provided by the team
• Following best-practice based on internal standards
• Database update & Maintenance

Perform document management services:

• Launching shells and managing document metadata
• Creating and Managing document libraries
• Scheduling documents for quality checks, finalization, and publishing
• Formatting and Editing documents to meet standards
• Collecting necessary forms, submitting documents to specified venues, maintaining documentation

Perform document finalization/publishing services:

• Review and format Word files to ensure as many compliance requirements are in the source file as possible.
• Render the Word files into PDFs.
• Preparing final eCTD-compliant PDFs of CMC regulatory documents using publishing software.
• Review the PDFs and edit them as needed to ensure that all regulatory requirements are met eCTD Publishing.
• Publish eCTD submissions as needed.

Minimum Qualification Requirements:

• B.Pharmacy/M.Pharmacy or equivalent degree in a scientific or related field with minimum 2 to 4 years of relevant experience.

Other Information/Additional Preferences

• eCTD Publishing experience.
• RIMS Experience
• Basic knowledge of CMC (preferred)
• Excellent MS Word and Adobe PDF skills
• Demonstrated team work skills and effectiveness in the areas of influence, leadership, and conflict resolution
• Experience in the pharmaceutical industry preferred
• High level of attention to detail and superior English-language skills
• Literature reviewing and evaluation capabilities
• Ability to multi-task and work under tight timelines
• Proficient with Microsoft Word, PowerPoint, Excel, and Desktop Publishing Software

Zwayam