Senior Medical Writer: Lead Regulatory Documents & Cross-Functional Collaboration

Openkrill; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Openkrill is seeking a highly organized senior medical writer to lead planning and preparation of high‑quality regulatory documents for drug development. You will partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to deliver protocols, publications, study reports, and module documents in line with client and agency guidelines.

Qualified candidates have 5+ years in medical writing in CRO/biotech/pharma, and a Bachelor's or higher in a

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharmaceutical fields.
• Bachelor's degree or higher in a relevant field.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2 and 5 documents.

Responsibilities

• Lead the execution of documents and manage timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion of documents.
• Ensure documents adhere to client processes, templates, and guidelines.
• Serve as an expert on client document management systems and tools.
• Lead document message development in collaboration with client.
• Plan and lead kickoff meetings; facilitate review feedback and comment resolution meetings.
• Ensure consistency across programs in messaging, formatting, and presentation.

Skills

Organizational skills

Cross-functional collaboration

Project management

Scientific writing

Fluent English communication

Attention to detail

Education

Bachelor's degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Collaborative authoring tools

Job description

Openkrill is seeking a highly organized senior medical writer to lead planning and preparation of high‑quality regulatory documents for drug development. You will partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to deliver protocols, publications, study reports, and module documents in line with client and agency guidelines.

Qualified candidates have 5+ years in medical writing in CRO/biotech/pharma, and a Bachelor's or higher in a