MDR - Sr Prin Clinical Research Spec - Exempt

Join our dynamic Clinical group of CAS located in the vibrant city of Mounds View, MN. This is an exciting opportunity to be part of a team that supports clinical-regulatory filings for pre-market and post-market technologies across all geographies, contributing to global medical affairs operations with real-time scientific assessments and dissemination.

Responsibilities

• Lead the authoring and critical review of scientific and Clinical Evaluation documents.
• Analyze complex clinical data into clear, accurate, and defensible written summaries.
• Ensure documents are scientifically sound and consistent.
• Function as a recognized independent Subject Matter Expert (SME) influencing decisions.
• Provide strategic clinical input to internal teams and leadership.
• Represent Clinical in cross-functional planning and help the organization understand the clinical implications of decisions.
• Oversee, design, plan, and develop clinical evaluation research studies.
• Prepare and author protocols and patient record forms.
• Conduct registered and nonregistered clinical studies of products that satisfy medical needs and/or offer commercial potential.
• Oversee and interpret results of clinical investigations for new drug, device, or consumer applications.
• Resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
• Prepare clinical trial budgets and manage clinical supply operations, site, and vendor selection.

Must-Have Skills

• Exceptional medical writing experience.
• Deep clinical research and clinical evidence development experience.
• Expert-level ability to write, edit, and finalize documents.
• Ability to connect scientific evidence to regulatory, commercial, and clinical needs.
• Exceptional medical writing and scientific communication skills.

Nice-to-Have Skills

• Foundational cardiac knowledge and experience with electrophysiology procedures/technology.

Work Hours & Interview Process

Normal day shift. The interview process includes 2-3 rounds, with a mix of video and phone interviews as needed.

Required Knowledge and Experience

Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience. A University Degree and a minimum of 10 years of relevant experience, or an advanced degree with a minimum of 8 years of relevant experience are required.