Regulatory Affairs Coordinator
Proclinical is currently recruiting for a Regulatory Affairs Coordinator with a biotechnology company located in Cambridge, MA. This is a role with the opportunity to learn and develop within the Reporting & Submissions team with a focus on regulatory intelligence and associated activities.
- Support the Reporting & Submissions team conducting routine activities such as monitoring of submissions, generating / reviewing metrics, inspection / audit readiness, assisting with quality reviews, ongoing training and other tasks, as assigned
Skills and Requirements:
- Bachelor's Degree in biological or natural science or regulatory affairs or Pharmacovigilance area
- Minimum 6 months to one-year industry experience, preferably in pharmacovigilance or regulatory area
- Understanding of global regulatory and pharmacovigilance terms and activities
- Ability to read and interpret global regulations / documents as received from various sources such as Cortellis
- Ability to identify, analyze, and summarize requirements / legislations related to Pharmacovigilance
- Business analyst skill, being able to read and differentiate relevant vs non-relevant regulatory intelligence received
- Ability to analyze and troubleshoot reporting issues
- Excellent organizational skills, including ability to prioritize work
- Excellent communication skills
- Ability to work independently and as a part of larger Global Case Management team
- Ability to identify, communicate, and provide solutions for areas of improvement
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.