Primary Job Function:
With limited supervision, coordinates and compiles regulatory documentation for submission to health authorities and contributes to Regulatory systems project to assure business needs are met and optimized for efficiency and effectiveness.
Track publishing related registration activities.
Communicate with business partners in order to track, complete, and distribute submissions.
Core Job Responsibilities:
Compile high quality submissions in compliance with technical requirements from regulatory authorities.
Project team participation to identify appropriate planning, formats, deliverables, and timelines associated with investigational and marketed product submissions across all therapeutic areas.
Coordinate submission publishing activities among internal Regulatory functions and external publishing technical resources (third party publishing resources and agency submission gateway owners).
Provide support as necessary to assure high quality published output and to meet established deadlines.
Input submission tracking information into registration tracking system.
Represent RA Operations on Regulatory sub teams as necessary, escalate timeline issues.
Implement internal process and standards relating to publishing and submission management.
Participate in and host team meetings and provide meeting minutes.
Plan and schedule own project related work.
Responsible for timely delivery of compliant regulatory submission output worldwide.
Works under limited supervision ensuring deliverable meets Abbott s internal standards.
Responsible and accountable for all steps assigned to Publishing during the submission process.
Responsible for compliant regulatory submission that impact the global Abbott business.
Accountable for tracking of complex worldwide submissions in the registration management tool.
Minimum Experience/Training Required:
2-5 years business related experience
1-3 years minimum publishing experience
Demonstrated ability to quickly learn new technology
Expertise with EDMS (Documentum based), publishing and or registration management systems , Adobe Acrobat or demonstrated experience with similar tools
Knowledge of regulations and instructions
Expertise with electronic submission formats like eCTD, ACTD and NeeS
Excellent written and oral communication skills