Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
Post : Associate Document Operations
JOB DESCRIPTION:
* 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 years Regulatory experience or 1-3 years in R&D or related area.
* Familiarity with pharmaceutical regulatory or labelling documents.
* Editing or 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.
Additional info:
Qualification: B. Pharm or B.Sc
Location: Mumbai
Job Type: Regulatory Operations
Industry type: Pharma
Click here: Apply Online
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