MMS
Senior Medical Writer (Remote)
at MMS
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. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high‑quality service and technology solutions that help our clients develop and market life‑changing therapies.
Responsibilities
Under minimal supervision, 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 protocols, investigator’s brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2.7.1–2.7.4, 2.5 documents, presentation materials, and publications to medical journals.
Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
Practice good internal and external customer service and be highly proficient with various regulatory writing styles and client templates & style guides.
Interact directly and independently with clients to coordinate all facets of projects; possess competent communication skills for project management.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, proactively consulting other project team members and departmental representatives for information or guidance as needed.
Mentor medical writers and other project team members involved in the writing process.
Requirements
At least 3–5 years of industry regulatory writing and clinical medical writing experience; minimum 3 years in the pharmaceutical industry.
Hold a Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline.
Substantial experience as a lead author on clinical study protocols and in leading and managing teams on regulatory documents with aggressive timelines.
Experience with regulatory submissions (clinical study reports) presented to authorities is a plus.
Strong understanding of clinical data, federal regulations, Good Clinical Practices, and ICH guidelines.
Exceptional writing and organizational skills; ability to multi‑task and manage competing deadlines.
Expertise in MS Word, Excel, PowerPoint, and related word‑processing tools.
Experience as a project lead or managing a project team.
Knowledge of orphan drug designations, PSP/PIPs is a plus.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Information Technology
Industry: Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr
at MMS
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. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high‑quality service and technology solutions that help our clients develop and market life‑changing therapies.
Responsibilities
Under minimal supervision, 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 protocols, investigator’s brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2.7.1–2.7.4, 2.5 documents, presentation materials, and publications to medical journals.
Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
Practice good internal and external customer service and be highly proficient with various regulatory writing styles and client templates & style guides.
Interact directly and independently with clients to coordinate all facets of projects; possess competent communication skills for project management.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, proactively consulting other project team members and departmental representatives for information or guidance as needed.
Mentor medical writers and other project team members involved in the writing process.
Requirements
At least 3–5 years of industry regulatory writing and clinical medical writing experience; minimum 3 years in the pharmaceutical industry.
Hold a Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline.
Substantial experience as a lead author on clinical study protocols and in leading and managing teams on regulatory documents with aggressive timelines.
Experience with regulatory submissions (clinical study reports) presented to authorities is a plus.
Strong understanding of clinical data, federal regulations, Good Clinical Practices, and ICH guidelines.
Exceptional writing and organizational skills; ability to multi‑task and manage competing deadlines.
Expertise in MS Word, Excel, PowerPoint, and related word‑processing tools.
Experience as a project lead or managing a project team.
Knowledge of orphan drug designations, PSP/PIPs is a plus.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Information Technology
Industry: Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr