MMS · 2 months ago
Senior Safety Writer (India, Remote)
United States
Full-time
Remote
Mid, Senior Level
4+ years expMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries. They are seeking a Senior Safety Writer who will be responsible for writing safety documents for regulatory agencies and producing high-quality patient CSR narratives while ensuring compliance with ICH and regulatory guidelines.
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
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
Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
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
Master's or PhD in a scientific, medical, or clinical discipline preferred
Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
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.
501-1000 employees
H1B Sponsorship
MMS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (8)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Lindsay Goldberg
2022-06-28Private Equity
Leadership Team
Christopher Schoonmaker
Chief Operating Officer
Kevin Chartier
Principal Advisor, Biostatistics and Submission Planning
Recent News
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