JOB
DESCRIPTION:
THE POSITION:
- The Document Operations Associate is responsible for processing of submission documents, use of document management tools, and use of publishing tools to create submission that meet Abbott/Regulatory Authority standards.
- The individual needs to work effectively with Operations team members, Regulatory Customers and Publishing to coordinate on time delivery of submission packages.
- The Individual must have excellent written & oral communication skills in English & be able to work with business partners globally.
- The individual will also perform other regulatory operations activities as needed.
- The individual supports departmental projects and less experienced colleagues.
CORE JOB
RESPONSIBILITIES:
- · Perform quality checks on own and other team members’ submissions components to ensure compliance with Abbott and regulatory authorities technical requirements.
- · Coordination of submission components readiness for publishing activities among internal Regulatory colleagues and external publishing to assure high quality documents and to meet established deadlines.
- · Project team participation to identify appropriate, formats, deliverables, and timelines associated with investigational and marketed product submissions.
- Contribute in settings standards and developing training materials for the consistent use of SharePoint and document management tools.
- · Contribute in process improvement, system enhancement, and provide assistance in troubleshooting issues with software and processes.
POSITION ACCOUNTABILITY
/ SCOPE:
- · Accountable for performing operational activities supporting the EPD regulatory organization.
MINIMUM EXPERIENCE /
REQUIREMENTS:
- · 1-3 year’s Regulatory experience or in its related area.
- · Ability to do pharmaceutical regulatory or labelling documents.
- · Editing/technical writing skill required.
- · Verbal and written communication skills.
- · Advanced experience with MS Word.
- · Document management and submission publishing software experience.
- · Ability to quickly learn, and use computer systems.
- · Must be process oriented with a strong attention to detail.
- · Ability to work in a fast-paced team environment and re-prioritize work to meet business needs.
EDUCATION:
- · Life Sciences Graduation or above.
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