Clinical Research

• Providing streamlined end-to-end solutions across each clinical trial
• Preparing CDPs with the aim of early launch and maximization of product value
• Preparing and revising Study Protocol Synopses, Study Protocols, and Informed Consent (ICF)
• Managing the preparation and revision of documents including Investigator’s Brochures, CSRs, clinical research manuscripts, NDA summaries and the clinical sections of NDA submission documents, etc.
• Reviewing blank Case Report Forms (CRFs), Statistical Analysis Plans (SAPs) and Pharmacokinetic Analysis Plans (PAPs), and performing the overall evaluation of clinical study results
• Working with and sharing duties with related functions in the preparation of documents for MFDS consultations, clinical trial notifications, medical specialist discussions and committees on drugs, preparation of responses to regulatory authority queries and negotiations with regulatory authorities
• Selecting and managing contract research organizations (CROs), and negotiating and managing clinical research activities with CROs, analytical laboratories and enrolment centers, etc.
• Maintains accurate tracking and reporting of study management data, and oversees the timely tracking of health authority/IRB/IEC submissions and approvals
• Identifying the opinion leaders in targeted therapeutic areas, creating strategic networks and establishing contacts with Key Opinion Leaders (KOL), unearthing and nurturing the next-generation leaders in the defined therapeutic areas

Pharmacovigilance

• Support to construction and maintenance of drug safety information system (Production and conclusion of Policy, SOP, PSP, PVA. Training)
• Execution of drug safety information system (Collection, reporting and archiving of drug safety information periodically and annually in accordance with SOP, PSP and/or PVA)
• Support to assurance of drug safety information system (Audit to drug safety information system at CRO in cooperation with audit dept. at CSK. Receipt of audit by audit dept.)
• Collection and compilation of regulatory requirements on drug safety information in Korea and Japan
• Support to installation of drug safety database

Regulatory Affairs

• Develops and maintains effective working relationships with the team members at C&C, the Sponsor and CRO/vendors 
• Coordinates the management of all activities during pre-IND/IND/NDA activities in collaboration with the Responsible Person of Regulatory
• Tracks and manages the process of Pre-IND consultation, IND preparation, IND submission (time control, documentations), IND review process in collaboration with Sponsors, C&C team and CRO
• Tracks and manages the process of CTD preparation, NDA submission and NDA review process; time control, documentation in collaboration with Sponsors, C&C team, and CRO
• Manages the post NDA maintenance
• Continue to expand the knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics