Senior Medical Writer (Remote)

MMS; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

MMS, a data-focused CRO, is seeking a Medical Writer to critically evaluate literature and prepare regulatory and clinical development documents, including protocols, investigator’s brochures, and study reports. The role requires leadership in writing projects, mentoring colleagues, and coordinating with clients to meet tight deadlines.

Ideal candidates will have 3+ years in pharma, strong regulatory writing experience, and advanced MS Office skills.

Qualifications

• Minimum 3 years in the pharmaceutical industry.
• 3-5 years of regulatory writing and clinical medical writing experience.
• Bachelor's, Master's, or Ph.D. in scientific/medical/clinical discipline.
• Substantial protocol experience as lead author.
• Experience leading and managing teams with aggressive timelines.
• Experience in regulatory submissions to authorities is a plus.
• Understanding of clinical data and regulatory writing standards.
• Exceptional writing skills and strong organizational ability.
• Expertise with MS Word, Excel and PowerPoint and related tools.
• Project lead or project team management experience.
• Knowledge of GCP and ICH guidelines is a plus.
• Orphan designation experience is a plus.

Responsibilities

• Critically evaluate literature to select primary materials for study design and bias assessment.
• Write and edit clinical development documents (protocols, brochures, study reports, consent forms, summaries).
• Produce materials for regulatory submissions and publications.
• Maintain timelines and manage writing workflow.
• Provide high-quality client service and communications.
• Adhere to client templates and style guides with accuracy.
• Coordinate with project team and clients to ensure project alignment.
• Mentor junior writers and other team members on writing processes.
• Take ownership of assignments and consult others as needed.

Skills

Regulatory writing

Medical writing

Project leadership

Mentoring

Client communication

MS Word

MS Excel

PowerPoint

Regulatory templates

Team coordination

Education

Bachelor's degree

Master's degree

PhD

Tools

MS Word

MS Excel

PowerPoint

Job description

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 percent customer satisfaction rating.

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 – 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. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. 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 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 process

Requirements

• 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 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
• Not required, but experience with orphan drug designations and PSP/PIPs a plus