Senior Medical Writer (Protocols)

MMS Holdings Inc; United States; On-site; USD 85,000 - 140,000; Full time

Job summary

MMS Holdings Inc is seeking an experienced Medical Writer to join our regulatory writing team in the United States. The role focuses on critically evaluating literature, drafting clinical development documents, and ensuring scientific rigor with minimal oversight.

The ideal candidate has 3+ years in pharmaceutical regulatory writing, lead author experience on clinical study reports, and outstanding writing and project coordination skills. MS Word, Excel, and PowerPoint proficiency is essential.

Qualifications

• At least 3 years of experience in the pharmaceutical industry in regulatory writing and clinical medical writing.
• Experience leading and authoring regulatory documents with aggressive timelines.
• Strong writing skills and ability to work with client templates and style guides.

Responsibilities

• Critically evaluate, analyze, and interpret medical literature to select primary resources for study design and regulatory submissions.
• Write and edit clinical development documents, including protocols, study reports, and related regulatory materials.
• Complete writing assignments promptly and maintain timelines and workflows.
• Mentor medical writers and project team members; communicate with clients to coordinate project activities.

Skills

Regulatory writing

Medical writing

Project leadership

Team management

Communication skills

Education

Bachelor's/Master's/PhD in scientific/medical field

Tools

MS Word

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.

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, mostly focusing on clinical protocols but the overall role mayinclude, but is not limited to, 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 andstyle 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