CRA SSU, Regulatory Experience

🕒 February 10

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide quality deliverables at the country level • Ensure compliance with submission/approval timelines • Monitor basic project finances • Review and comply with Standard Operating Procedures and Work Instructions • Prepare and submit various regulatory documents

🎯 Requirements

• At least 2 years of regulatory experience • Knowledge of Standard Operating Procedures (SOPs) • Ability to monitor financial aspects of projects • Familiarity with pre-submission and approval timelines • Skills in document management for Trial Master Files (TMF)

🏖️ Benefits

• support for career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program