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.
Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharmas international awards programs for the last three consecutive years.
Responsibilities
- Critically evaluate, analyze, and interpret 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 clinical protocols, investigators brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.12.7.4, and 2.5 documents, presentation materials, and publications to medical journals.
- Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
- Practice good internal and external customer service and be highly proficient with styles of writing for various regulatory documents.
- Expert proficiency with client templates & style guides, and interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects.
- Contribute substantially to, or manage, 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.
Qualifications
- At least 35 years of industry regulatory writing and clinical medical writing experience, with a strong background in pharmaceutical industry.
- Hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline.
- Substantial clinical study protocol experience as lead author.
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
- Experience in regulatory submissions (clinical study reports) presented to regulatory authorities.
- Understanding of clinical data and exceptional writing skills.
- Excellent organizational skills and ability to multitask.
- 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.
- Experience with orphan drug designations and PSP/PIPs a plus.
#J-18808-Ljbffr