Senior Medical Writer: Regulatory Submissions Expert

MMS; Denver (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

MMS is a Denver-based, data-focused CRO providing regulatory submission support for pharma, biotech and medical device trials. The Medical Writer will interpret literature, prepare regulatory documents and manage writing projects in a fast-paced environment.

Ideal candidates have 3+ years in pharmaceutical regulatory writing, strong MS Word/PowerPoint skills, and experience leading teams under tight timelines. Strong communication and knowledge of ICH guidelines are a plus.

Qualifications

• 3+ years in pharmaceutical industry with regulatory/clinical writing experience
• Lead author experience on regulatory documents is a plus
• Strong written and verbal communication, organizational and multitasking skills
• Familiarity with federal regulations, GCP, ICH guidelines is beneficial

Responsibilities

• Critically evaluate literature, select material for study design and regulatory documents
• Write and edit clinical development documents including protocols, investigator brochures, study reports and modules 2.x documents
• Meet timelines and manage writing workflows; provide client-focused service and communication
• Mentor junior writers and coordinate with project teams and departments
• Lead or co-lead project teams and ensure quality and regulatory compliance

Skills

Regulatory writing

Clinical writing

Team leadership

MS Word

MS Excel

PowerPoint

Communication skills

ICH guidelines

Education

Bachelor/Master/PhD in scientific/medical field

Tools

MS Word

Excel

PowerPoint

Job description

MMS is a Denver-based, data-focused CRO providing regulatory submission support for pharma, biotech and medical device trials. The Medical Writer will interpret literature, prepare regulatory documents and manage writing projects in a fast-paced environment.

Ideal candidates have 3+ years in pharmaceutical regulatory writing, strong MS Word/PowerPoint skills, and experience leading teams under tight timelines. Strong communication and knowledge of ICH guidelines are a plus.