As our Senior Medical Affairs Associate, you will provide scientific expertise and guidance to the Clinical Affairs team in clinical trials sponsored by Penumbra. You will participate in the review, processing and reporting of safety data in clinical investigations, providing medical input in trial design, protocol preparation and report writing.
What You'll Work On
Ensure timely processing, review and reporting of safety data for medical device under investigation in worldwide clinical trials.
Provide input to our Quality Assurance and Regulatory Affairs departments for the processing of reportable events to regulatory agencies worldwide.
Provide input to Data Management in the review and reconciliation of serious adverse events (SAEs).
Assist in the design and preparation of clinical studies, including protocol writing, Case Report Form(CRF) preparation, and drafting of patient informed consent.
Prepare SAE narratives in the Safety Section of clinical trial reports.
Participate in the collection, review, and processing of imaging scans from investigational sites for independent review by outside experts
Assist in the preparation of clinical safety data for review by outside safety panels such as Data Safety Monitoring Boards or Clinical Events Committees.
What You Bring
A passion for science, medicine, and clinical research.
The desire to work with and contribute to the work of a great team.
An advanced degree in Public Health, Nursing or a related discipline.
At least two years of industry experience in medical monitoring, safety operations, clinical/scientific research, and/or 5+ years of clinical experience.
Excellent oral, written, and interpersonal communication skills.
Prior medical device or pharmaceutical industry experience strongly preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.