Senior Medical Writer
Company: MMS
Location: Gaithersburg
Posted on: February 25, 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 & Responsibilities* Under minimal supervision, the
Medical Writer will critically evaluate, analyze, and interpret the
medical literature to select primary resource materials for
adequate study design, statistical significance, scientific rigor
and absence of bias* Write and edit clinical development documents,
including but not limited to, clinical protocols, investigator's
brochures, clinical study reports, subject consent forms,
integrated safety and efficacy summaries, presentation materials
and publications to medical journals* Complete writing assignments
in a timely manner* Maintain timelines and workflow of writing
assignments* Practice good internal and external customer service*
Highly proficient with styles of writing for various regulatory
documents* Expert proficiency with client templates & style guides*
Interact directly and independently with client to coordinate all
facets of projects; competent communicator skills for projects*
Contribute substantially to, or manages, production of interpretive
guides* Take ownership of a given assignment, proactively
consulting other project team members and other department
representatives for information or guidance as necessary* Mentor
medical writers and other members of the project team who are
involved in the writing processRequirements* At least 3 years of
previous experience in the pharmaceutical industry* Must have at
least 3-5 years of industry regulatory writing and clinical medical
writing experience* The ideal candidate would hold a Bachelors,
Masters, or Ph.D. in scientific, medical, clinical discipline*
Substantial Oncology experience required* Substantial clinical
study protocol experience, as lead author, required* Experience
leading and managing teams while authoring regulatory documents
with aggressive timelines* Experience in regulatory submissions
(clinical study reports) presented to regulatory authorities a
plus* Understanding of clinical data* Exceptional writing skills
are a must* Excellent organizational skills and the ability to
multi-task are essential prerequisites* Candidate must be an expert
in MS Word, Excel, PowerPoint, and related word processing tools*
Experience being a project lead, or managing a project team* Strong
understanding of federal regulations, Good Clinical Practices, and
ICH guidelines a plus* Substantial clinical study protocol
experience, as lead author, required* Experience leading and
managing teams while authoring regulatory documents with aggressive
timelines* Not required, but experience with orphan drug
designations and PSP/PIPs a plusPowered by JazzHR9XZ01ElArQ
Keywords: MMS, Washington DC , Senior Medical Writer, Advertising , Gaithersburg, DC
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