Clinical Scientist & Medical Writer – Medical Devices

Balt Brasil; Irvine (CA); On-site; USD 160,000 - 170,000; Full time

Job summary

Balt Group is seeking a Clinical Scientist – Medical Writer to join our Clinical Evidence team. The role focuses on clinical study reports, CIP/CSR writing, literature reviews, and publication strategy, with cross-functional collaboration and interaction with FDA and other stakeholders.

The successful candidate will have a strong background in clinical science, 5+ years in medical device clinical studies, and at least 2 years of medical writing experience.

Qualifications

• PhD or PharmD preferred; advanced Medical/Life Sciences degrees may be considered.
• Minimum 5 years in Medical Device Industry designing and reporting clinical studies; at least 2 years in medical writing (CIPs/CSRs).
• Experience interpreting scientific/clinical study information.

Responsibilities

• Lead implementation of Clinical Evidence activities.
• Author protocols for product approvals and expanded indications.
• Prepare Clinical Study Reports and regulatory responses.
• Lead publication strategy and coordination with investigators.
• Support regulatory submissions and data presentation to stakeholders.

Skills

Medical writing

Communication skills

Teamwork

Pressure handling

MS Office

Education

PhD or Pharm.D preferred

Tools

Adobe Acrobat

Job description

Balt Group is seeking a Clinical Scientist – Medical Writer to join our Clinical Evidence team. The role focuses on clinical study reports, CIP/CSR writing, literature reviews, and publication strategy, with cross-functional collaboration and interaction with FDA and other stakeholders.

The successful candidate will have a strong background in clinical science, 5+ years in medical device clinical studies, and at least 2 years of medical writing experience.