Fortrea, a global Contract Research Organization (CRO), is dedicated to transforming drug and device development. With decades of clinical development expertise, Fortrea provides innovative solutions across over 20 therapeutic areas. Operating in approximately 100 countries, the company collaborates with pharmaceutical, biotechnology, and medical device organizations to bring life-changing therapies to patients. Fortrea’s mission is to revolutionize clinical trials and ensure the rapid delivery of groundbreaking treatments. Learn more at Fortrea.
Responsibilities in the Job
As a Regulatory Operations Assistant II, you will play a pivotal role in ensuring the quality and compliance of technical documentation and data analysis. Key responsibilities include:
- Delivering technical reports in compliance with cGMP standards within deadlines using a right-first-time approach.
- Preparing stability reports by compiling data tables, creating graphical representations, and drawing preliminary conclusions about pharmaceutical products or active substances.
- Performing statistical evaluations of data using statistical software.
- Extracting and evaluating data trends, providing conclusions based on analyses.
- Coordinating document management activities within the document management system.
- Ensuring quality and compliance with procedures and customer requirements.
- Identifying and resolving issues related to technical documentation, troubleshooting conflicts, and providing solutions promptly.
Qualifications
To succeed in this role, candidates must meet the following qualifications:
- Bachelor’s degree in a relevant field such as Pharmacy, Life Sciences, or related disciplines.
- Experience in regulatory operations or technical documentation within the pharmaceutical or biotechnology industry.
- Familiarity with cGMP standards and regulatory requirements.
- Proficiency in statistical analysis and use of statistical software.
Skills
The ideal candidate will possess:
- Strong analytical and problem-solving skills.
- Attention to detail with a focus on accuracy and compliance.
- Excellent organizational and time management abilities.
- Proficiency in document management systems and data evaluation tools.
- Effective communication skills for collaboration with cross-functional teams.
How to Apply
Interested candidates are encouraged to apply immediately as the application deadline is January 28, 2025. Follow these steps to submit your application:
Application Link 1 (PUNE)
Application Link 2 (Mumbai)
