Senior Medical Writer — Remote (Regulatory/Clinical)

MMS Holdings Inc; Austin (TX); Remote; USD 75,000 - 100,000; Full time

Job summary

MMS Holdings Inc in Austin, Texas seeks a skilled Medical Writer to evaluate medical literature and write essential clinical documents. Candidates should have 3-5 years of regulatory writing experience within the pharmaceutical industry.

The Medical Writer is responsible for maintaining project timelines and mentoring team members while ensuring compliance with rigorous standards. Exceptional writing skills, proficiency with MS tools, and a background in scientific disciplines are essential for this role.

Qualifications

• At least 3-5 years of industry regulatory writing and clinical medical writing experience.
• Substantial clinical study protocol experience, as lead author, required.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines.

Responsibilities

• Critically evaluate medical literature and select primary resource materials.
• Write and edit clinical development documents.
• Maintain timelines and workflow of writing assignments.
• Mentor medical writers and team members involved in writing processes.

Skills

Regulatory writing

Clinical medical writing

Exceptional writing skills

Organization and multi-tasking

MS Word proficiency

Communication skills

Education

Bachelor's, Master's, or Ph.D. in scientific, medical, clinical discipline

Tools

MS Word

MS Excel

MS PowerPoint

Job description

MMS Holdings Inc in Austin, Texas seeks a skilled Medical Writer to evaluate medical literature and write essential clinical documents. Candidates should have 3-5 years of regulatory writing experience within the pharmaceutical industry.

The Medical Writer is responsible for maintaining project timelines and mentoring team members while ensuring compliance with rigorous standards. Exceptional writing skills, proficiency with MS tools, and a background in scientific disciplines are essential for this role.