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MMS · 1 day ago

Senior CSR Narrative Writer (India, Remote)

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

MMS is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries. They are seeking a Senior CSR Narrative Writer responsible for writing safety documents and patient CSR narratives, ensuring compliance with regulatory guidelines and managing client interactions.

BiotechnologyHealth CareLife Science

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

Qualification

CSR narrative writingICH guidelines understandingMicrosoft Word proficiencyOncology backgroundElectronic Document ManagementWritten EnglishCommunication skillsInterpersonal skillsAttention to detailOrganizational skills

Required

Experience in leading complex CSR narratives projects, preference for Oncology background

University graduate in scientific, medical, clinical discipline or related field, or related experience

4-6 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

Preferred

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

Company

MMS

MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges.

Founded in 2006

Canton, Michigan, USA

501-1000 employees