Senior Medical Writer (Remote)
Company: MMS
Location: Canton
Posted on: September 18, 2023
Job Description:
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 or follow MMS on .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, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5
documents, 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 JazzHR
Keywords: MMS, Canton , Senior Medical Writer (Remote), Healthcare , Canton, Michigan
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