Associate Director, Regulatory Publishing
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Job Description
Associate Director leading Regulatory Publishing activities at Vertex Pharmaceuticals. Overseeing publishing processes and managing submissions throughout their lifecycle, ensuring compliance with agency standards.
Responsibilities:
- Accountable for leading publishing activities on a portfolio level
- Responsible for the maintenance and lifecycle management submissions
- Lead complex submission work across programs
- Ensure submission content is tracked, compiled, validated, and delivered in the required format
- Perform quality control (QC) reviews on vendor work
- Contribute to long-term resource planning, including publishing capacity needs
Requirements:
- Requires Bachelor’s Degree in life sciences or technology area
- Typically requires 9 years of Regulatory Operations/Publishing experience or equivalent combination of education and experience
- Extensive experience in industry standard publishing software and validation systems
- Vendor management/outsourcing experience
- Ability to prioritize portfolio of publishing activities on selected programs
- Ability to train and educate other team members
- Knowledge of health authority procedures/guidances regarding electronic submissions
Benefits:
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Opportunity for professional development
- Overtime pay
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