Clinical Evaluation Medical Writer - Remote

Getinge; United States; Hybrid; USD 105,000 - 115,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Disability Benefits

FSAs for health and dependent care

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

the company in the United States is seeking a Clinical Affairs professional to lead the generation of Clinical Evaluation Reports and post‑market communications. The role supports PMCF activities, literature reviews, and regulatory submissions with physicians and medical professionals across a fast‑paced environment.

The ideal candidate has 3+ years of medical writing experience in the medical device space, strong regulatory knowledge (EU MDR/ISO guidelines), and excellent communication and

Qualifications

• Bachelors Degree in a relevant scientific discipline or equivalent experience.
• Minimum 3 years medical writing experience, preferably in clinical evaluations for medical devices.
• Medical writing certification is a plus.
• High attention to detail and accuracy; strong communication skills.
• Excellent project management, organizational, and problem-solving abilities.
• Proficient in PubMed, Embase; familiarity with DistillerSR and EndNote.

Responsibilities

• Lead and contribute to CER and related documentation development.
• Participate in PMCF team activities and literature reviews.
• Perform systematic literature searches and data analyses for regulatory submissions.
• Draft and edit clinical study docs and reports (protocols, CSRs, ISR/CSR).
• Support manuscript preparation for journals and abstract submissions.
• Maintain SOPs within Clinical Affairs processes.
• Coordinate with internal teams and external CROs/vendors as needed.
• Travel as required by projects.

Skills

Medical writing

Clinical evaluations

PMCF

Regulatory knowledge

Literature review

Project management

Communication

Education

Bachelor's degree in a relevant scientific discipline

Tools

DistillerSR

EndNote

PubMed

Embase

Job description

the company in the United States is seeking a Clinical Affairs professional to lead the generation of Clinical Evaluation Reports and post‑market communications. The role supports PMCF activities, literature reviews, and regulatory submissions with physicians and medical professionals across a fast‑paced environment.

The ideal candidate has 3+ years of medical writing experience in the medical device space, strong regulatory knowledge (EU MDR/ISO guidelines), and excellent communication and