Senior Drug Safety Writer
Company: MMS
Location: Charleston
Posted on: February 23, 2021
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Job Description:
MMS is an award-winning, data-focused CRO that supports the
pharmaceutical and biotech industries with a proven, scientific
approach to complex trial data and regulatory submission
challenges. Strong industry experience 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 was named as the Best
Global Biotech CRO in the 2018 International Life Sciences Awards.
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
skillsRequirements* Experience in aggregate reports (DSURs,
PBRER/PSUR) and RMPs* College 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* 1-3 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
systemPowered by JazzHR7I6xBQJKQt
Keywords: MMS, Charleston , Senior Drug Safety Writer, Advertising , Charleston, South Carolina
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