Legal Assistant

Clinical Research Malaysia; Kuala Lumpur; On-site; MYR 36,000 - 60,000; Full time

Job summary

Clinical Research Malaysia is seeking a Junior Legal Assistant to support clinical operations, business development and administration. You will draft and review Clinical Trial Agreements and amendments, and handle NDA, MOU and other agreements, ensuring compliance with laws and guidelines.

The role involves coordinating with internal teams and external parties, maintaining records, and conducting legal research.

Qualifications

• Bachelor’s degree in law or equivalent
• 1 year working experience in legal firm or in-house legal
• Meticulous, detailed-oriented, well-organized, able to work independently to meet deadlines
• Excellent communication and interpersonal skills
• Excellent writing skills
• Familiar with legal and contract terminology
• Hardworking, enthusiastic, and capable of handling paperwork

Responsibilities

• Draft and timely review contracts, esp. Clinical Trial Agreement and amendments
• Draft and review other legal documents (MOU, NDA, PSA, Collaborative Agreement)
• Assist in LHDN stamping adjudication submission
• Manage archiving and retrieval of legal documents and records
• Prepare Legal and Regulatory Affairs meeting minutes
• Assist in ad hoc tasks for Legal and Regulatory Affairs
• Conduct legal research for department publications
• Be contact point for CTA System and internal e-signature software
• Stay updated on legal & regulatory guidelines and compliance
• Maintain rapport with industry stakeholders incl. pharma, CROs, MOH personnel
• Support department events and undertakings

Skills

Legal drafting

Contract terminology

Communication

Interpersonal skills

Writing skills

Attention to detail

Teamwork

Time management

Education

Bachelor's degree in law

Job description

Junior Legal & Fresh Graduates are encouraged to apply

JOB SUMMARY

Legal Assistant is to perform legal activities which are related to 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 Duties & Responsibilities:-

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

Draft and review other legal documents such as MOU, Non-Disclosure Agreement, Professional Service Agreement, Collaborative Agreement and other Extramural Agreement

Assist in legal documents LHDN Stamping Adjudication submission

Manage the archiving, maintenance and retrieval of legal related documents, including agreements, correspondence, meeting minutes and other legal records, ensuring proper record keeping and compliance with the Company's document retention policies

Prepare Legal and Regulatory Affairs Department’s meeting minutes=

Assist upon request in ad hoc tasks and works related to Legal and Regulatory Affairs Department

Conduct legal research for Legal and Regulatory Department’s publication works

Become the point of contact for any issue related to internal Clinical Trial Agreement System (CTA System), internal ADOBE E-Signature software etc

Always keep abreast of any updates related to legal & compliance guidelines and regulatory framework

Maintain 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/officers

Support Legal and Regulatory Affairs Department in various undertakings including handling events related to the department.

BASIC REQUIREMENTS

Bachelor’s degree in law or equivalent

At least 1 year working experience in legal firm or in-house legal

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 team

Excellent communication and interpersonal skills

Excellent writing skills

Familiar with legal and contract terminology

Hardworking, enthusiastic, and capable of handling paperwork

Clinical Research Malaysia (CRM) is a Global Trusted Research Management Organisation established by the Ministry of Health Malaysia in 2012. The organisation is guided by the principles of Humanity, Stability, and Sustainability in providing global clinical trial solutions and enabling a thriving clinical research ecosystem in the country.

Clinical Research Malaysia (CRM) is a Global Trusted Research Management Organisation established by the Ministry of Health Malaysia in 2012. The organisation is guided by the principles of Humanity, Stability, and Sustainability in providing global clinical trial solutions and enabling a thriving clinical research ecosystem in the country.