JOB SUMMARY Intern is to perform legal activities which are related to the clinical operations, business development and other relevant administration of the company including clinical trials agreements. This position is to initiate, communicate, liaise, report, update, coordinate and work together with other functions within the company or external relevant parties as per requirements.
KEY RESPONSIBILITIES Assist to draft and timely review contract particularly Clinical Trial Agreement and applicable amendments to the Clinical Trial Agreement with due respect to any applicable laws, rules and regulations which includes but not limited to Contracts Act 1950, Personal Data Protection Act 2010, Medical (Amendment) Act 2012 and Medical Regulations 2017 and Malaysian Guideline for Good Clinical Practice Assist to draft and review other legal documents such as MOU, Non-Disclosure Agreement, and Professional Service AgreementPrepare department's correspondencesAssist in legal documents LHDN Stamping Adjudication submissionOrganize and file legal related documents (agreements, letters, meeting minutes etc.)Prepare Legal and Regulatory Affairs Department's meeting minutesAssist upon request in ad hoc tasks and works related to Legal and Regulatory Affairs DepartmentConduct legal research for Legal and Regulatory Department's publication worksAssist in any issues related to internal Clinical Trial Agreement System (CTA System), internal ADOBE E-Signature software etcAlways keep abreast with any updates related to legal & compliance guidelines and regulatory frameworkMaintain good rapport with Industry stakeholders specifically Clinical Research Associate of multi-national pharmaceutical company, contract research organization (CRO) and Ministry of Health's medical personnel/officersSupport Legal and Regulatory Affairs Department in various undertakings including handling event related to the department BASIC REQUIREMENTS Bachelors' degree in Law or equivalent (fresh graduates are welcome)Meticulous, detailed-oriented, well-organized, able to work independently to meet strict deadlines, take responsible for every job assigned and able to work as a teamExcellent communication and interpersonal skillsExcellent writing skillsFamiliar with legal and contract terminologyHardworking, enthusiastic, resourceful and capable of handling paperwork