CSR Narrative Writer (Malaysia, Remote, US EST Shift) at MMS Holdings Inc. | Torre
CSR Narrative Writer (Malaysia, Remote, US EST Shift)
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MMS Holdings Inc.

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

MMS Holdings Inc.
Emma
Emma
You'll advance drug development by crafting critical safety documents for global regulatory submissions.
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Full-time

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Emma of Torre.ai
 9 days ago

Requirements and responsibilities

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 ResponsibilitiesResponsible for writing safety documents intended for submission to regulatory agencies.Responsible for writing patient CSR narratives and producing high quality documentsPractices excellent internal and external customer serviceGood understanding of MS Word for advanced writing techniquesAddress client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to clientEnsure documents comply with appropriate ICH and regulatory guidelinesInteract directly and independently with clientAbility to follow MMS and sponsor processesPractices internal and external leadership skillsJob 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 experiencePrior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writingMaster’s or PhD in a scientific, medical, or clinical discipline preferredMin 2 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment Understands ICH guidelines, as applicable to medical writing for clinical studiesExcellent written English skillsHigh degree of organization and able to manage multiple projects at any given timeAttention to detail and committed to excellence in all aspects of their workExcellent communication and interpersonal skillsProficient in Microsoft Word and Adobe AcrobatExperience in the use of an Electronic Document Management system
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