Senior Medical Writer (Remote)

MMS; Denver (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

MMS is a Denver-based, data-focused CRO providing regulatory submission support for pharma, biotech and medical device trials. The Medical Writer will interpret literature, prepare regulatory documents and manage writing projects in a fast-paced environment.

Ideal candidates have 3+ years in pharmaceutical regulatory writing, strong MS Word/PowerPoint skills, and experience leading teams under tight timelines. Strong communication and knowledge of ICH guidelines are a plus.

Qualifications

• 3+ years in pharmaceutical industry with regulatory/clinical writing experience
• Lead author experience on regulatory documents is a plus
• Strong written and verbal communication, organizational and multitasking skills
• Familiarity with federal regulations, GCP, ICH guidelines is beneficial

Responsibilities

• Critically evaluate literature, select material for study design and regulatory documents
• Write and edit clinical development documents including protocols, investigator brochures, study reports and modules 2.x documents
• Meet timelines and manage writing workflows; provide client-focused service and communication
• Mentor junior writers and coordinate with project teams and departments
• Lead or co-lead project teams and ensure quality and regulatory compliance

Skills

Regulatory writing

Clinical writing

Team leadership

MS Word

MS Excel

PowerPoint

Communication skills

ICH guidelines

Education

Bachelor/Master/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.

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