Position Overview
We are seeking a Senior Clinical Evaluation Medical Writer to develop clinical evaluation and post-market regulatory documentation for medical devices. This role will evaluate clinical evidence, conduct literature reviews, and support regulatory compliance activities.
Key Responsibilities
- Author CEPs, CERs, PMCF Plans/Reports, SSCPs, and PSURs.
- Conduct literature reviews and evaluate clinical evidence.
- Analyze and summarize clinical, scientific, and post-market data.
- Develop and maintain regulatory documentation.
- Support audit, regulatory, and submission-related responses.
- Collaborate with cross-functional teams to support project objectives.
- Lead projects and manage timelines, deliverables, and stakeholder communications.
Required Qualifications
- Bachelor's degree with 4+ years of relevant experience, or an advanced degree with 2+ years of relevant experience.
- Experience authoring CEPs, CERs, PMCF Plans/Reports, SSCPs, and PSURs.
- Experience conducting literature reviews and clinical evidence evaluations.
- Knowledge of medical device clinical evaluation and regulatory requirements.
- Strong project management and communication skills.
- Ability to manage multiple projects independently.
Preferred Qualifications
- Experience supporting regulatory submissions or audits.
- Experience with post-market surveillance activities.
- Experience leading cross-functional projects or mentoring team members.
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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].