OVERVIEW
We are currently seeking a highly skilled Clinical Evaluation Medical Writer to join a well-known client’s team in Mounds View, MN. This role is responsible for analyzing and integrating diverse clinical evidence to evaluate product safety and performance, while identifying potential data gaps and risks. This position works closely with cross-functional stakeholders to define clinical strategies, support regulatory interactions, and deliver high-quality clinical documentation. This is a critical role with direct impact on regulatory success and patient safety within the medical device space.

RESPONSIBILITIES
•    Identify, compile, and analyze diverse data sources, including clinical investigations, scientific literature, preclinical data, and post-market experience, to assess product safety and performance.
•    Lead and support development of clinical evaluation reports (CERs) and clinical dossiers in alignment with global regulatory requirements.
•    Collaborate cross-functionally (R&D, Clinical, Quality, Regulatory, Marketing) to define and execute clinical evaluation strategies.
•    Develop literature search strategies and manage evidence collection using tools such as ReadCube or similar platforms.
•    Assess data gaps and risks, propose mitigation strategies, and track findings through cross-functional collaboration.
•    Conduct risk/benefit analyses and evaluate State of the Art (SOTA) for relevant therapy areas and products.
•    Maintain up-to-date knowledge of clinical evaluation regulations, guidance, and industry best practices.
•    Support regulatory interactions, including preparing responses to questions, addressing deficiencies, and participating in discussions with regulatory agencies.
•    Create and manage document timelines and project plans, ensuring timely delivery of clinical documentation.
•    Review and assess technical documentation (e.g., risk management files, IFUs) against available clinical data and literature.
•    Perform document review, editing, formatting, and approval processes to ensure high-quality deliverables.
•    Provide guidance, mentoring, and coaching to team members when needed.
•    Contribute to process improvements, policy development, and best practice implementation within the clinical function.

EXPERIENCE
•    Minimum of 4+ years of experience in clinical research, clinical evaluation, or clinical evidence generation (or 2+ years with an advanced degree).
•    Demonstrated experience conducting end-to-end clinical evaluations strongly preferred.
•    Experience in cardiac rhythm management devices is highly desirable.
•    Experience using literature management tools (e.g., ReadCube) preferred.
•    Familiarity with global regulatory requirements related to clinical evaluations and medical device submissions.
•    Experience interacting with regulatory agencies and supporting submission activities is a plus.

EDUCATION
•    Bachelor’s degree in a relevant scientific or healthcare discipline required.
•    Advanced degree preferred.

TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE
•    Strong analytical skills with the ability to synthesize complex clinical data into clear, actionable insights.
•    Excellent written and verbal communication skills, particularly in scientific and regulatory documentation.
•    Strong project management and organizational skills, with the ability to manage multiple priorities and timelines.
•    Ability to collaborate effectively across cross-functional teams and influence stakeholders.
•    Detail-oriented mindset with a commitment to quality and compliance.
•    Proactive problem solver with the ability to anticipate risks and drive solutions.
•    Ability to mentor and guide colleagues in clinical evaluation best practices.
 

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].

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