CSR Narrative Writer (Malaysia, Remote, US EST Shift)

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Roles and Responsibilities

• Responsible for writing safety documents intended for submission to regulatory agencies.
• Responsible for writing patient CSR narratives and producing high quality documents
• Practices excellent internal and external customer service
• Good understanding of MS Word for advanced writing techniques
• Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client
• Ensure documents comply with appropriate ICH and regulatory guidelines
• Interact directly and independently with client
• Ability to follow MMS and sponsor processes
• Practices internal and external leadership skills

Job Requirements (Minimum Education / Experience / Training / Skills)

• Experience in leading complex CSR narratives projects, preference for Oncology background. 
• University graduate in scientific, medical, clinical discipline or related field, or related experience
• Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
• Master’s or PhD in a scientific, medical, or clinical discipline preferred
• Min 2 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment 
• Understands ICH guidelines, as applicable to medical writing for clinical studies
• Excellent written English skills
• High degree of organization and able to manage multiple projects at any given time
• Attention to detail and committed to excellence in all aspects of their work
• Excellent communication and interpersonal skills
• Proficient in Microsoft Word and Adobe Acrobat
• Experience in the use of an Electronic Document Management system