Senior Medical Writer

Summary

Join MMS, a leading CRO supporting the pharmaceutical, biotech, and medical device industries, as a Medical Writer. You will be responsible for critically evaluating and analyzing medical literature, writing and editing clinical development documents, and collaborating with clients to ensure timely and high-quality deliverables. This role requires at least 5 years of experience in the pharmaceutical industry, including regulatory writing and clinical medical writing, and a strong understanding of clinical data and regulatory guidelines.

Requirements

• At least 5 years of previous experience in the pharmaceutical industry
• Must have at least 5 years of industry regulatory writing and clinical medical writing experience
• Substantial clinical study protocol experience, as lead author, required
• Experience authoring regulatory documents with aggressive timelines
• 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

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 may include, 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 and 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

Preferred Qualifications

• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus