Core Job Responsibilities:
- Provide strategic input into the development of defined tasks for assigned products/projects seeking guidance where appropriate.
- Provide input into global strategic plans as appropriate.
- Monitor actual vs. planned activities and timelines and identify issues impacting project progression.
- Assist with the preparation and review of technical strategic regulatory documentation for agency submission.
- Responsible for ensuring accuracy and quality of documentation.
Position Accountability/Scope:
Effective Interface within Region and broader Abbott Organization
- Works primarily with Regional organization (commercial, supply, quality.etc), Affiliate RA staff and Divisional RA contacts.
Project or Geographic or TA Accountability
-Assist with projects within one or more therapeutic areas.
- Assist with geographic intelligence, liaison and affiliate support as provided and directed by manager – this role will primarily interact with Russia, CIS and Turkey – thus Russian or Turkish language skills is an advantageous
-Project assignments and strategic direction are provided by manager.
-Routine supervision of project activities is required
Scope of Accountability (budget, resources, planning)
-Accountable for assigned project/task scope; completion with scheduled completion date
- No direct budgetary responsibility
-Adheres to departmental guidelines on expenses
-Identifies opportunities for cost savings
Resolution, Prediction of regulatory issues
Resolves current issues, learns and adjusts based on prior results.
Awareness and application of Regulatory Intelligence
Maintain awareness of new draft legislation and guidelines.
Impact on regulatory policy and regulations
Follows policy to ensure standard interpretation of regulations for defined project or task.
Minimum Education:
Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject
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