Senior Medical Writer (Remote - US)

MMS; Louisville (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

MMS is seeking a Medical Writer to support regulatory documentation for pharma, biotech and medical device projects. The role focuses on critical evaluation of literature, writing clinical protocols, study reports and safety summaries, and coordinating with sponsors to ensure high-quality, timely deliverables.

Ideal candidates have 3–5 years of regulatory writing and clinical medical writing experience, with strong MS Word skills, excellent writing ability, and a track record of leading project

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• 3–5 years of industry regulatory writing and clinical medical writing experience.
• Candidates should hold a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial experience with lead authoring of clinical study protocols.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions (clinical study reports) is a plus.
• Understanding of clinical data and standards.
• Exceptional writing, organizational, and multitasking skills.
• Expert in MS Word, Excel, PowerPoint and related tools.
• Experience as project lead or managing a project team is preferred.
• Knowledge of federal regulations, Good Clinical Practices, ICH guidelines a plus.
• Orphan drug designations and PSP/PIPs experience a plus (not required).

Responsibilities

• Evaluate and interpret medical literature to select primary resources for study design and regulatory documents.
• Write and edit clinical development documents including protocols, investigator's brochures, study reports, consent forms, safety and efficacy summaries and Module 2.x documents.
• Maintain timelines and workflow for writing assignments.
• Mentor medical writers and project team members involved in the writing process.
• Interact with clients to coordinate projects and ensure quality results.

Skills

Regulatory writing

Clinical writing

Project leadership

MS Word

MS Excel

Communication skills

Attention to detail

Team mentoring

Education

Bachelor's degree in life sciences

Master's degree or PhD preferred

Tools

MS Project

EndNote

Adobe Acrobat

Regulatory submission tools

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