Crinetics Pharmaceuticals
Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome
Manager, Regulatory Submission
Location
California
Posted
33 days ago
Salary
$110K - $136K / year
Bachelor Degree8 yrs expEnglish
Job Description
• Manage submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities
• Participate in submission team meetings
• Coordinate multiple concurrent interrelated activities for submission projects for products in the delivery of published submissions within required timelines
• Anticipate obstacles and develop solutions within the team
• Coordinate submission publishing with publishers and provides notification to ensure all required resources are available to meet submission timelines
• Prepare content planner for publishing and work with team members to resolve publishing issues
• May perform publishing tasks
• Assist with team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances
Job Requirements
- Bachelor’s degree
- Minimum 8 years of relevant experience in the biotech or pharmaceutical industry
- Minimum 2 years of experience working with submission content planning
- Strong working knowledge of regulatory submission publishing standards and procedures including word processing and regulatory publishing software
- Preferred: Experience working with Veeva RIM document management system
- Experience working with LORENZ docuBridge FIVE
- Experience working with Accenture StartingPoint
- Utilizing Smartsheet for submission content planning
- Experience producing eCTD U.S. and MAA submission
Benefits
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
- Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
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