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.
Job Responsibilities
- Act as a project lead and author clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Modules 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5, presentation materials and publications to medical journals
- Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the relevant clinical/scientific data sources to develop high-quality deliverables
- Complete project assignments per timelines
- Maintain timelines and workflow of writing assignments
- Practice excellent internal and external customer service, communication, and teamwork.
- Highly proficient with document templates, MW tools and style guides for authoring various regulatory deliverables
- Interact directly and independently with client to coordinate all facets of projects; manage full project lifecycles, including client meetings, KOMs and CRMs
- Identify and mitigate project risks
- 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
Job Requirements
- At least 5 years of previous experience in the Pharma/CROindustry
- Must have at least 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 experience as lead author on clinical study protocols and clinical study reports
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Experience in authoring regulatory submissions documents for INDs, NDAs, or MAAs a plus
- Strong understanding and ability to interpret clinical data
- Exceptional writing and communication 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, related word processing tools, and must have worked on document management systems
- Experience being a project lead, and managing a project team a must
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines
- Flexible to work with clients in different time zones
