Regulatory Affairs Implementation Coordinator
4 semanas atrás
Estimated Salary: $60,000 - $90,000 per year
About UsWe are a leading global biotechnology company dedicated to helping our customers make the world healthier, cleaner and safer. Our innovative solutions in life sciences, clinical diagnostics, and applied therapies enable researchers in laboratories, hospitals, molecular diagnostic labs and clinics around the world to make new discoveries, develop new treatments and improve patient outcomes.
Job DescriptionWork Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
The Regulatory Affairs Implementation Coordinator plays a critical role in supporting the implementation of amendments within assigned projects, ensuring that deliverables meet customer expectations and contracted milestones are met.
A Day in the Life:
- Supports the development and execution of amendment implementation strategies at country and site levels, within a region or globally.
- Assists in understanding amendment scope, classification, and timelines.
- Liaises with country resources in Clarity to obtain necessary information and updates.
- Collaborates with project teams on amendment planning, financial coverage, and risk assessments.
- Tracks amendment-related actions and facilitates updates within applicable system(s).
- Schedules and conducts progress check calls with local teams.
- Updates Principal Investigator Amendment Notification and Amendment Implementation Letters.
- Liaises with Regulatory Affairs Leads and project teams to assess amendment submission requirements and country submission timelines.
- Updates forecasting and actuals for amendment-related units according to Clarity monthly deadlines.
- Informs project team members when amendment activities have been completed.
- Identifies and mitigates risks associated with amendments.
Keys to Success:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
Benefits:
- A competitive salary range of $60,000 - $90,000 per year.
- A comprehensive benefits package, including medical, dental, and vision insurance.
- A generous 401(k) matching program.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
How You'll Thrive:
- You will thrive in an office environment with exposure to electrical office equipment.
- You will be required to work different shifts, long varied hours, and occasional travel.
- You will frequently be stationary for 6-8 hours per day, with repetitive hand movement and frequent mobility required.
- You will occasionally crouch, stoop, bend, and twist your upper body and neck.
- You will lift and carry light to moderate objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.
- You will access and use various computer software developed both in-house and off-the-shelf.
- You will communicate information and ideas effectively, with the ability to listen and understand information presented through spoken words and sentences.
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