Senior Medical Writer | Lead Regulatory Docs & Protocols

MMS; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

MMS, a data-focused CRO, seeks an experienced Medical Writer to lead regulatory documentation for pharma/biotech trials. You will author protocols, clinical study reports, and integrated summaries, coordinating across teams and with clients to ensure on-time delivery.

The role demands 5+ years in regulatory/clinical writing, strong writing skills, and familiarity with GCP/ICH and FDA regulations. Experience across multiple time zones and with submission platforms is a plus.

Qualifications

• 5+ years in pharma/CRO industry.
• 5+ years regulatory and clinical medical writing experience.
• Advanced degree in scientific/medical discipline.
• Lead author on clinical study protocols and clinical study reports.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in authoring regulatory submissions documents for INDs, NDAs, or MAAs is a plus.
• Strong understanding and ability to interpret clinical data.
• Excellent writing and communication skills.
• Excellent organizational skills and multitasking abilities.
• MS Word, Excel, PowerPoint proficiency; experience with document management systems.

Responsibilities

• Lead projects and author clinical development documents (protocols, IBs, CSRs, SPFs, and related submissions).
• Under minimal supervision, evaluate, analyze, and interpret data to develop high-quality deliverables.
• Complete project assignments per timelines.
• Maintain timelines and workflow of writing assignments.
• Provide excellent internal and external customer service, communication, and teamwork.
• Proficient with document templates, MW tools and style guides for regulatory deliverables.
• Interact with client to coordinate all facets of projects; manage full project lifecycles, including client meetings, KOMs and CRMs.
• Identify and mitigate project risks.
• Own assignments and consult other team members and departments for information.
• Mentor medical writers and other project team members.

Skills

Regulatory writing

Clinical writing

Project leadership

Team management

MS Word

MS Excel

MS PowerPoint

Attention to detail

Communication skills

Regulatory submissions

Education

Bachelor/Master/PhD in scientific/medical field

Tools

Document management systems

Regulatory submission platforms

MW style guides/templates

Job description

MMS, a data-focused CRO, seeks an experienced Medical Writer to lead regulatory documentation for pharma/biotech trials. You will author protocols, clinical study reports, and integrated summaries, coordinating across teams and with clients to ensure on-time delivery.

The role demands 5+ years in regulatory/clinical writing, strong writing skills, and familiarity with GCP/ICH and FDA regulations. Experience across multiple time zones and with submission platforms is a plus.