Medical Writer

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Writer based in the United States.

This remote opportunity is designed for a scientific communications professional who is passionate about advancing healthcare through accurate and impactful clinical documentation.

The role focuses on developing high-quality medical writing deliverables that support clinical evaluations, investigations, and regulatory submissions. You will analyze clinical evidence, conduct literature reviews, and transform complex scientific data into clear, compliant documentation.

The position offers the opportunity to collaborate with multidisciplinary teams, including medical, regulatory, quality, and research professionals. You will contribute to initiatives that support patient safety, regulatory compliance, and the advancement of innovative healthcare solutions.

Accountabilities

The Medical Writer is responsible for creating and developing clinical documentation that supports medical device evaluations, regulatory activities, and clinical strategy. Key responsibilities include:

• Lead and contribute to the development of Clinical Evaluation Reports (CERs) and related clinical documentation, including planning, literature review, data assessment, and analysis.
• Support Post-Market Clinical Follow-up (PMCF) activities through clinical data reviews, literature assessments, and evaluation documentation.
• Conduct comprehensive and systematic literature searches using databases and search platforms.
• Analyze clinical evidence from manufacturer data and published literature to support clinical development strategies.
• Write, edit, and review clinical study documentation, including protocols, investigator brochures, periodic reports, and clinical study reports.
• Ensure documentation meets regulatory expectations and is suitable for submission to regulatory agencies.
• Develop and support scientific manuscripts, abstracts, and conference submissions.
• Collaborate with medical professionals to ensure scientific accuracy and data integrity.
• Contribute to the optimization of clinical affairs procedures, processes, and standard operating practices.
• Partner with internal teams and external stakeholders, including clinical vendors, research organizations, and healthcare experts.

Requirements

The ideal candidate has experience in medical writing, clinical research documentation, and regulatory environments. Required qualifications and skills include:

• Bachelor's degree in a relevant scientific discipline or equivalent.
• Minimum of 3 years of medical writing experience.
• Previous experience with clinical evaluations within the medical device industry is highly preferred.
• Medical writing certification is a plus.
• Strong understanding of clinical affairs regulations, including EU MDR (2017/745), MEDDEV, MDCG, ISO standards, and ICH guidelines.
• Experience conducting literature reviews using tools such as PubMed or Embase.
• Familiarity with literature review and reference management tools such as DistillerSR and EndNote is preferred.
• Exceptional written and verbal communication skills.
• Strong analytical, organizational, and problem-solving skills.
• Excellent project management abilities.
• Advanced proficiency with Microsoft Office applications.

Benefits

The role offers a competitive compensation package and comprehensive benefits:

• Salary range: $105,000 - $115,000 annually.
• Remote work flexibility within the United States.
• Health, dental, and vision insurance.
• 401(k) retirement plan with company matching.
• Paid time off and wellness initiatives.
• Life insurance and disability benefits.
• Parental and caregiver leave programs.
• Tuition reimbursement.

How Jobgether Works

We use an AI-powered matching process to ensure your application is reviewed quickly and fairly. The final decision and next steps are managed by the hiring company.

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