Senior Change Management Lead - Clinical Regulatory Remote

System One; Sunnyvale (CA); Remote; USD 179,000 - 193,000; Full time

Job summary

System One, Inc. is seeking a Senior Change Management Lead on a remote contract basis in Sunnyvale, CA. The role focuses on supporting Clinical Evaluation Reports under MDR to assist CE marking and regulatory submissions.

The ideal candidate will have 2–4 years medical writing experience, CER writing in medical devices, and strong literature review and scientific writing capabilities, with excellent communication and project management skills.

Qualifications

• Minimum 2–4 years of medical writing experience.
• 0–2 years of CER writing experience in medical device industry preferred.
• Strong experience in literature searches, reviews and data appraisal of scientific data.
• Excellent scientific writing and communication skills.
• High attention to detail with ability to manage multiple projects.

Responsibilities

• Author CER sections and perform literature searches.
• Review the literature and write clinical summaries for products and procedures.
• Support global Regulatory activities with timely data submissions.
• Collaborate with internal teams on CER development plans.
• Proofread, edit, format, and incorporate review comments.
• Assist with manuscript preparation including abstracts and posters.
• Possibly author protocols and routine Clinical Study Progress Reports.
• Ensure compliance with SOPs and regulatory guidelines (GCP, US and OUS).

Skills

Medical writing

Literature review

Regulatory submissions

Clinical evaluation reports

Communication skills

Data analysis

Education

MD/PhD/MS

Tools

MS Word

EndNote

PubMed

Job description

System One, Inc. is seeking a Senior Change Management Lead on a remote contract basis in Sunnyvale, CA. The role focuses on supporting Clinical Evaluation Reports under MDR to assist CE marking and regulatory submissions.

The ideal candidate will have 2–4 years medical writing experience, CER writing in medical devices, and strong literature review and scientific writing capabilities, with excellent communication and project management skills.