Accountabilities:
The Medical Writer is responsible for creating and developing clinical documentation that supports medical device evaluations, regulatory activities, and clinical strategy. This role requires strong scientific writing skills, analytical thinking, and the ability to collaborate with internal and external stakeholders. 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 to support clinical evaluations, regulatory requirements, and state-of-the-art assessments.
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 and external audiences.
Develop and support scientific manuscripts, abstracts, and conference submissions based on clinical study data and evidence.
Collaborate with medical professionals to ensure scientific accuracy, data integrity, and alignment with publication requirements.
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, with strong attention to detail and scientific communication abilities. Required qualifications and skills include:
Bachelor’s degree in a relevant scientific discipline or equivalent combination of education and experience.
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 and guidance, including EU MDR (2017/745), MEDDEV guidance, MDCG guidance, ISO standards, and ICH clinical research guidelines.
Experience conducting literature reviews using tools such as PubMed, Embase, or similar research databases.
Familiarity with literature review and reference management tools such as DistillerSR and EndNote is preferred.
Exceptional written and verbal communication skills with the ability to translate complex scientific information clearly.
Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities.
Excellent project management abilities with experience delivering high-quality work within deadlines.
Ability to work independently while collaborating effectively within cross-functional teams.
Professional communication skills when interacting with physicians, clinical experts, and external partners.
Advanced proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
Flexibility to accommodate changing priorities, urgent timelines, and project-based travel requirements when needed.
Benefits:
The role offers a competitive compensation package and comprehensive benefits designed to support employee well-being, professional development, and work-life balance, including:
Salary range of approximately $105,000–$115,000 annually, depending on experience, skills, and qualifications.
Remote work flexibility within the United States.
Health, dental, and vision insurance coverage.
401(k) retirement plan with company matching contributions.
Paid time off and wellness initiatives.
Health assistance resources and employee support programs.
Life insurance and short- and long-term disability benefits.
Health and dependent care flexible spending accounts.
Commuter benefits.
Parental and caregiver leave programs.
Tuition reimbursement opportunities.
Opportunity to contribute to meaningful healthcare innovation and global medical advancements.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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