Urology Product Specialist

4 weeks ago


Minneapolis, Minnesota, United States Coloplast Full time

Job Summary

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We are seeking a highly skilled Urology Product Specialist to join our team at Coloplast. This position will play a critical role in driving and managing clinical documentation to support marketing and regulatory needs, as well as providing clinical expertise and advice to internal stakeholders.

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About the Role

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This position is responsible for defining near, medium, and long-term objectives covering a broad range of medical affairs activities, such as:

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  • Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical evidence">
  • Identifying external clinical opinions, perceptions, and trends that influence Coloplast performance globally, and where warranted, develop appropriate mitigating strategies">
  • Executing the scientific agenda, by engaging researchers through Coloplast activities and grants, and other evidence generation activities">
  • Supporting the development of any regulatory or quality-associated documentation">
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Main Responsibilities

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This position will include:

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  • Developing and delivering medical device technical documents supporting product launch and sustaining activities">
  • Leveraging the latest literature, regulations, and guidance to build and execute on evidence strategies">
  • Serving as a medical expert for relevant products and associated clinical conditions">
  • Providing clinical expertise and advice to internal stakeholders">
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Key Qualifications

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To be considered for this role, you must have 5+ years' experience within clinical research and/or medical affairs activities, preferably with medical devices.

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You should hold a Bachelor's degree in a health science or biotech area, with an advanced degree in the health sciences preferred (MS, PhD, PharmD, MD).

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A strong understanding of ISO 14155, FDA, GCP, and MDR regulations is essential, along with the ability to travel up to 20-30%.

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About Coloplast

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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs.

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We employ about 16,000 people and have products available in more than 143 countries, making us one of the world's leading medical device companies.

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As a Coloplast employee, you are expected to conduct business to the highest ethical and professional standards, comply with applicable laws and regulations, and adhere to our company policies.

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Coloplast is committed to a policy of Equal Employment Opportunity (EEO) and employs individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance, or any other protected classification.

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Salary: $130,000 - $160,000 per year

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Location: Denmark



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