Senior Medical Writer (Remote)

MMS; Columbia (SC); Remote; USD 70,000 - 110,000; Full time

Job summary

A leading company in data-driven medical writing seeks an experienced Medical Writer to create comprehensive clinical documents and manage submissions. The ideal candidate will have strong regulatory writing skills, educational background in sciences, and proven teamwork experience, ensuring submission quality and compliance with regulations.

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• Extensive experience as a lead author on clinical study protocols.
• Knowledge of regulatory submissions and federal regulations such as GCP and ICH guidelines.

Responsibilities

• Writing and editing clinical development documents.
• Managing the production of interpretive guides and mentoring team members.
• Ensuring proper study design and scientific rigor in clinical documents.

Skills

Regulatory writing

Project management

Customer service

Education

Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline

Tools

MS Word

Excel

PowerPoint

Job description

MMS is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submissions.

With strong industry experience, technology-enabled services, and a data-driven approach to drug development, MMS is a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.

Operating across four continents, MMS maintains a 97 percent customer satisfaction rating and has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the past three years.

For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Responsibilities

Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret medical literature to select primary resource materials, ensuring proper study design, statistical significance, scientific rigor, and absence of bias.

Responsibilities include writing and editing clinical development documents such as clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, 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 for medical journals.

The Medical Writer must complete assignments timely, maintain workflow, and practice excellent customer service. They should be highly proficient in various styles of regulatory writing, familiar with client templates and style guides, and capable of interacting directly with clients independently.

The role involves contributing to or managing the production of interpretive guides, taking ownership of assignments, and mentoring other writers and team members.

Requirements

• At least 3 years of experience in the pharmaceutical industry, with 3-5 years in regulatory and clinical medical writing.
• A Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Extensive experience as a lead author on clinical study protocols.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Knowledge of regulatory submissions, clinical data, and federal regulations such as GCP and ICH guidelines.
• Expertise in MS Word, Excel, PowerPoint, and project management skills.
• Experience in project leadership or team management.
• Additional experience with orphan drug designations, PSPs, or PIPs is a plus.