Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies.  We help our clients to generate data about safety and efficacy of medications and bring the best ones to market.  By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life.  Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence.  PSI is a mature company with standards and practices, but we do not stand still.  Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description

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.

Office-based in Seoul

Your role:

Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applicationsCommunicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related mattersReview translations of essential documents subject to clinical trial submissionTrack the regulatory project documentation flowReview documents to greenlight IP release to sitesManage safety reporting to authoritiesDeliver regulatory training to project teams Assist with feasibility research and business development requests

QualificationsCollege/University degree or an equivalent combination of education, training, and experienceAt least 3 to 5 years of prior experience with clinical trial submissions in KoreaFull working proficiency in English and KoreanProficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skills

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.