MMS
Apply for the Senior Medical Writer (Remote)
role at
MMS .
About 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% customer satisfaction rating.
Our mission is to deliver high‑quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life‑changing therapies to positively improve lives worldwide.
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 but not limited to clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1–2.5 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.
Use highly proficient style for various regulatory documents.
Apply expert proficiency with client templates and style guides.
Interact directly and independently with client to coordinate all facets of projects; demonstrate competent communication skills for projects.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as necessary.
Mentor medical writers and other members of the project team involved in the writing process.
Requirements
At least 3 years of previous experience in the pharmaceutical industry.
3–5 years of industry regulatory writing and clinical medical writing experience.
Holder of a Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline.
Substantial clinical study protocol experience as lead author.
Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
Experience in regulatory submissions (clinical study reports) presented to regulatory authorities (plus).
Understanding of clinical data.
Exceptional writing skills.
Excellent organizational skills and the ability to multi‑task.
Expertise 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 (plus).
Experience with orphan drug designations and PSP/PIPs (plus).
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Information Technology
Referrals increase your chances of interviewing at MMS by 2x.
Get notified about new Senior Medical Writer jobs in
Raleigh, NC .
#J-18808-Ljbffr
role at
MMS .
About 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% customer satisfaction rating.
Our mission is to deliver high‑quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life‑changing therapies to positively improve lives worldwide.
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 but not limited to clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1–2.5 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.
Use highly proficient style for various regulatory documents.
Apply expert proficiency with client templates and style guides.
Interact directly and independently with client to coordinate all facets of projects; demonstrate competent communication skills for projects.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as necessary.
Mentor medical writers and other members of the project team involved in the writing process.
Requirements
At least 3 years of previous experience in the pharmaceutical industry.
3–5 years of industry regulatory writing and clinical medical writing experience.
Holder of a Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline.
Substantial clinical study protocol experience as lead author.
Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
Experience in regulatory submissions (clinical study reports) presented to regulatory authorities (plus).
Understanding of clinical data.
Exceptional writing skills.
Excellent organizational skills and the ability to multi‑task.
Expertise 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 (plus).
Experience with orphan drug designations and PSP/PIPs (plus).
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Information Technology
Referrals increase your chances of interviewing at MMS by 2x.
Get notified about new Senior Medical Writer jobs in
Raleigh, NC .
#J-18808-Ljbffr