Job Description

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Responsible for clinical, scientific, and health economic evidence development to support the regulatory and business requirements. Specific responsibilities include literature search, clinical evidence appraisal, clinical evaluation report writing, annual safety and performance update, white paper development, and support of education training, podium presentation and manuscript publication. Also included are clinical investigational study protocol development, study management, data collection, and study report writing to meet the regulatory requirements for registration approval/renewal as well as business requirements for post-market research of medical devices regulated by the US FDA, European regulatory authorities, or other regional/country regulatory agencies.

Principal Duties and Responsibilities

* Literature search, clinical evidence appraisal, clinical evaluation report writing, annual safety and performance update, white paper development, and support of education training, podium presentation, and manuscript publication.
* Clinical investigational study protocol development, study management, data collection, and study report writing.
* Project management of Investigator-Initiated Research including scientific review, committee review, contract management, project oversight and payment.
* Cross-functional collaboration and support with Marketing, Regulatory Affairs, Engineering, Quality, etc.

Expected Areas of Competence

* Demonstrates ability to effectively communicate ideas and persuade others to accomplish goals and objectives.
* Sets priorities consistent with company goals and focuses on high priority opportunities.
* Allocates resources (e.g. time, dollars) consistent with priorities.
* Takes steps to understand external customer and/or internal client needs and translate this knowledge into effective decisions.
* Drives innovation through embracing diversity and change
* Delivers results and drives for continuous improvement. Has high performance expectations and holds others accountable for results. Takes action to enhance performance based on experiences and feedback.
* Demonstrates principled leadership and sound business ethics; shows consistency among principles, values and behaviors
* Encourages and supports information sharing and collaboration across departments.
* Takes actions that are best for the company versus his or her individual unit.
* Demonstrates proficiency in writing clinical study protocols and clinical evaluation reports.
* Demonstrates teamwork and ability to train/mentor colleagues in study management issues.
* The successful candidate must possess outstanding organizational and analytical skills and attention to detail.

Education/Experience Requirements

* A bachelors degree in the health, life sciences, or engineering disciplines.
* Certification as a Certified Clinical Research Professional (CCRP) is preferred.
* Minimum of 5 years experience preferred monitoring outcomes and randomized studies and, IDE study management/monitoring experience including facilitating approval review with Institutional Review Boards.
* In-depth understanding of product knowledge regarding clinical application and ability to act as department resource for inquiries regarding specific use.
* In-depth understanding of clinical data system and analytical report development from studies.
* Has thorough understanding of the Code of Federal Regulations, Title 21 sections applicable to Good Clinical Practice and the ability to use sound judgment independently on issues related to studies.

Travel Requirements

* Up to 20%

Additional Information

EOE M/W/Vet/Disability.

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.