Job Description

Company Description
We are the company that cares \xe2\x80\x93 for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.


Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. This is an Office-based position located in Bangalore, India Your role:

• Prepare independently clinical trial submission dossiers for Regulatory and Regulatory Authorities, including Import and Export license applications.
• Communicate with regulatory authorities, project teams and vendors on regulatory-related matters.
• Review translations of essential documents subject to clinical trial submission.
• Track the regulatory project documentation flow.
• Review documents to greenlight IP release to sites.
• Manage safety reporting to authorities.
• Deliver regulatory training to project teams.
• Assist with feasibility research and business development requests.

Qualifications

• College/University degree or an equivalent combination of education, training and experience.
• 2-3 years of hands-on experience with clinical trial submissions. (Independent preparation of submissions dossiers for DCGI, including preparation of application forms, Executive Summary, country-specific statement, as well as country-level customization of patient documents.)
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to learn, plan and work in a dynamic team environment.
• Communication, collaboration, and problem-solving skills.

Additional Information
PSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 2,700 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives. How are we different? PSI is privately owned by the very people who founded the company more than 25 years ago, and they\xe2\x80\x99re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms. Being a Part of the Team As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents. You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback. Growth Opportunities PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. The PSI Advantage PSI CRO has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is the fourth year in a row that PSI CRO received CRO Leadership Awards in all 5 categories, also including Expertise and Capabilities. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations. Unique Opportunity If you\xe2\x80\x99re looking to advance your career in clinical research at a company growing organically into new regions around the world, we would love to hear from you! Global CROs don\xe2\x80\x99t expand their business to new locations every day, so don\xe2\x80\x99t miss your chance.