Sr Clin Eval Med Writer - Exempt

Advanced Clinical; Coon Rapids (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k benefits

Job summary

Advanced Group in Minnesota seeks a Senior Clinical Evaluation Medical Writer to support clinical evaluation and regulatory documentation for medical devices. This role will author and maintain CEPs and CERs, assess clinical evidence, and support regulatory submissions and post-market activities.

Ideal candidates hold a Bachelor’s degree with 4+ years of relevant experience (or an advanced degree with 2+ years), plus strong scientific writing, literature review, and evidence assessment skills.

Qualifications

• Bachelor's degree with 4+ years of relevant experience, or an advanced degree with 2+ years.
• Experience authoring clinical evaluation and post-market surveillance documents.
• Knowledge of medical device clinical evaluation and regulatory requirements.
• Strong scientific writing, literature review, and evidence assessment skills.
• Strong project management and communication skills.
• Ability to manage multiple projects and stakeholders.

Responsibilities

• Author and maintain CEPs, CERs, PMCF plans/reports, SSCPs, and PSURs.
• Conduct literature reviews and evaluate clinical evidence to support device safety and performance.
• Develop regulatory documentation and responses to audit or submission inquiries.
• Maintain clinical evaluation records and literature databases.
• Collaborate with cross-functional teams to support regulatory and product development activities.
• Manage projects and ensure timely delivery of clinical evaluation documents.

Skills

Scientific writing

Literature review

Evidence assessment

Project management

Communication

Education

Bachelor's degree with 4+ years

Advanced degree with 2+ years

Job description

Position Overview

We are seeking a Senior Clinical Evaluation Medical Writer to support clinical evaluation and regulatory documentation for medical devices. This role will author and maintain clinical evaluation documents, assess clinical evidence, and support regulatory submissions and post-market activities.

We are seeking a Senior Clinical Evaluation Medical Writer to support clinical evaluation and regulatory documentation for medical devices. This role will author and maintain clinical evaluation documents, assess clinical evidence, and support regulatory submissions and post-market activities.

Key Responsibilities

• Author and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), PMCF Plans/Reports, SSCPs, and PSURs.
• Conduct literature reviews and evaluate clinical evidence to support device safety and performance.
• Develop regulatory documentation and responses to audit or submission inquiries.
• Maintain clinical evaluation records and literature databases.
• Collaborate with cross-functional teams to support regulatory and product development activities.
• Manage projects and ensure timely delivery of clinical evaluation documents.

Required Qualifications

• Bachelor's degree with 4+ years of relevant experience, or an advanced degree with 2+ years of relevant experience.
• Experience authoring clinical evaluation and post-market surveillance documents.
• Knowledge of medical device clinical evaluation and regulatory requirements.
• Strong scientific writing, literature review, and evidence assessment skills.
• Strong project management and communication skills.
• Ability to manage multiple projects and stakeholders.

Preferred Qualifications

• Experience with CEPs, CERs, PMCF Plans/Reports, SSCPs, and PSURs.
• Experience supporting regulatory submissions, audits, or inspection responses.
• Medical device industry experience.

Benefits

• 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 [e-mail].