Overview In this Medical Writer role at MMS, you will evaluate literature and craft regulatory-grade clinical documents to support development programs. You'll work closely with clients and cross-functional teams to ensure scientific rigor, timely delivery, and compliance with regulatory standards. The position combines hands-on writing with mentorship and project leadership, offering impact across trials and submissions. You'll contribute to high-quality submissions that advance therapies and patient outcomes in a global, data-driven environment.
Responsibilities- Critically evaluate medical literature to inform study design and bias-free interpretation
- Write and edit clinical development documents (protocols, investigator's brochures, CSRs, ICFs, Module 2.x, and publications) and presentations
- Maintain writing timelines and manage workflow for multiple assignments
- Provide excellent internal and external customer service and adapt to client templates and style guides
- Interact directly with clients to coordinate all project facets and act as a competent project communicator
- Contribute to, or lead, production of interpretive guides and manage ownership of assignments
- Mentor medical writers and project teams involved in the writing process
- Proactively consult team members and other departments for information and guidance as needed
- Lead or participate in project teams and ensure timely delivery under aggressive timelines
Key requirements- At least 3 years in the pharmaceutical industry
- 3-5 years of industry regulatory writing and clinical medical writing experience
- Bachelor, Master, or Ph.D. in scientific, medical, clinical discipline
- Substantial clinical study protocol experience as lead author
- Experience leading and managing teams with tight deadlines
- Experience in regulatory submissions (CSRs) a plus
- Strong understanding of clinical data and regulatory requirements
- Exceptional writing and organizational skills
- Expert in MS Word, Excel, PowerPoint, and related tools
- Project lead experience or team management
- Knowledge of federal regulations, GCP, and ICH guidelines a plus
- Experience with orphan drug designations and PSP/PIPs a plus
- Excellent communication and client-facing skills
- Mentoring and leadership aptitude
- Collaborative, cross-functional teamwork
- Regulatory writing expertise
- Clinical study report (CSR) production
- Proposal and document formatting per templates/style guides
