Lead Regulatory Medical Writer — Clinical Submissions

MMS; Boston (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

MMS is an innovative CRO focused on regulatory-grade trial data and submissions. The Medical Writer will evaluate literature, draft protocols, summaries, and regulatory documents with expert accuracy under timelines.

Ideal candidates have 3+ years in pharma regulatory writing, strong MS Word skills, and proven leadership in project teams, delivering high-quality materials for submissions to regulatory authorities.

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• 3–5 years of regulatory writing and clinical medical writing experience.
• 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 is essential.
• Not required, but experience with orphan drug designations and PSP/PIPs a plus.

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 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.

Skills

Regulatory writing

Project leadership

Excellent writing

Regulatory knowledge (FDA/ICH/GCP)

Education

Bachelor's/Master's/PhD in scientific/medical discipline

Tools

MS Word

Excel

PowerPoint

Job description

MMS is an innovative CRO focused on regulatory-grade trial data and submissions. The Medical Writer will evaluate literature, draft protocols, summaries, and regulatory documents with expert accuracy under timelines.

Ideal candidates have 3+ years in pharma regulatory writing, strong MS Word skills, and proven leadership in project teams, delivering high-quality materials for submissions to regulatory authorities.