Senior Medical Writer - Medical Devices & Regulatory

PPG US ProPharma Group, LLC; Chicago (IL); Hybrid; USD 120,000 - 160,000; Full time

Job summary

ProPharma Group in the United States seeks an experienced Medical Writer to lead cross-functional projects, author regulatory and clinical documents, and mentor junior writers. The role emphasizes strong communication with clients and internal teams to ensure on-time, compliant deliverables.

The candidate should have 7+ years of experience in writing clinical/regulatory documents for drugs, biologics, or devices, and a solid grasp of FDA and ICH guidelines, with hybrid work options and a

Qualifications

• Advanced knowledge of clinical research principles and data presentation.
• Strong understanding of FDA and applicable regulatory requirements.
• Experience with regulatory submission processes and documents.
• Expert word processing skills in MS Word with tables, graphs and figures.

Responsibilities

• Ensure communication on project- and program-related matters with medical writing leadership and internal resources.
• Manage clinical program documents (protocols, IBs, ICFs, study reports, etc.).
• Lead cross-functional coordination to manage medical writing and QC deliverables.
• Independently author high-quality medical writing deliverables across phases and therapeutic areas.
• Supervise, train, and mentor less experienced medical writers.
• Adhere to regulatory standards (ICH, FDA, EU guidelines) and templates.
• Manage client expectations, lead meetings, and maintain deliverable timelines.
• Collaborate with SMEs to produce deliverables and coordinate QC reviews.
• Review statistical outputs for content accuracy and consistency.
• Perform peer review of documents written by others when required.
• Support administrative tasks such as timelines and trackers.

Skills

Clinical research

Regulatory knowledge

Regulatory submissions

MS Word

Project management

Communication

AMA style

Relationship building

Time management

Team collaboration

Growth mindset

Education

Bachelor's degree or higher in medical/scientific discipline

Tools

MS Word

Job description

ProPharma Group in the United States seeks an experienced Medical Writer to lead cross-functional projects, author regulatory and clinical documents, and mentor junior writers. The role emphasizes strong communication with clients and internal teams to ensure on-time, compliant deliverables.

The candidate should have 7+ years of experience in writing clinical/regulatory documents for drugs, biologics, or devices, and a solid grasp of FDA and ICH guidelines, with hybrid work options and a