Senior Medical Writer (Remote)

MMS; Miami (FL); Remote; USD 75,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a talented Clinical Medical Writer with expertise in regulatory submissions and clinical development documentation. This role involves writing and editing key documents, mentoring team members, and ensuring compliance with industry standards. Ideal candidates will have a strong background in medical writing, exceptional organizational skills, and a passion for contributing to impactful healthcare solutions.

Qualifications

• Minimum 3 years of experience in the pharmaceutical industry.
• 3–5 years of regulatory and clinical medical writing experience.
• Extensive clinical study protocol experience as a lead author.

Responsibilities

• Critically evaluate and interpret medical literature for study design.
• Write and edit clinical development documents including protocols and reports.
• Mentor medical writers and project team members.

Skills

Clinical Study Protocol Experience

Regulatory Submissions Experience

Exceptional Writing Skills

Organizational Skills

Multitasking Ability

Education

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

Tools

MS Word

Excel

PowerPoint

Job description

About MMS

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 submission challenges.

With a global presence 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 help our clients develop and market life-changing therapies to improve lives worldwide.

MMS values talented staff as the driver of our success.

We prioritize identifying and attracting top talent and providing ongoing training to enhance core skills.

At MMS, enthusiasm, collaboration, and teamwork are fostered, recognizing that a diverse, global talent pool strengthens our company.

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

Responsibilities

• Under minimal supervision, critically evaluate, analyze, and interpret medical literature to select primary resources for 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, safety and efficacy summaries, Module 2.7.1–2.7.4, 2.5 documents, presentation materials, and journal publications.
• Complete writing assignments promptly, maintaining timelines and workflow.
• Practice excellent internal and external customer service.
• Proficiently use styles for various regulatory documents, client templates, and style guides.
• Interact independently with clients to coordinate project aspects; communicate effectively with project teams.
• Contribute to or manage the production of interpretive guides.
• Take ownership of assignments, proactively consulting team members and departments for guidance.
• Mentor medical writers and project team members involved in writing processes.

Requirements

• Minimum 3 years of experience in the pharmaceutical industry.
• 3–5 years of regulatory and clinical medical writing experience.
• Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline.
• Extensive clinical study protocol experience as a lead author.
• Experience leading and managing teams under tight deadlines.
• Experience with regulatory submissions, such as clinical study reports, is advantageous.
• Understanding of clinical data and exceptional writing skills.
• Strong organizational skills and multitasking ability.
• Expertise in MS Word, Excel, PowerPoint, and related tools.
• Experience as a project lead or managing project teams.
• Knowledge of federal regulations, GCP, and ICH guidelines is a plus.
• Experience with orphan drug designations, PSPs, or PIPs is beneficial.