Regulatory affairs specialist Jobs in München

Job Title : Sr. Medical Affairs Specialist, Global Medical Communications

Our Company

Insulet Corporation is an innovative medical device company dedicated to simplifying the lives of people living with diabetes. Founded in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives using our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of people living with diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. The Company’s world headquarters and state-of-the-art automated manufacturing facility are located in Acton, Massachusetts with global offices in the U.K., France, Germany, Netherlands, Canada, Mexico, Australia, and the United Arab Emirates. Omnipod products are available in 24 countries around the world.

Insulet’s Medical Affairs team adds to our innovation journey by providing medical expertise to the organization to inform research and development, evidence generation and data dissemination, professional engagement, and medical education to advance our mission.

This Position

Reporting to the Senior Manager of Medical Affairs, Global Medical Communications, the Sr. Medical Affairs Specialist position at Insulet will leverage clinical and disease state expertise to inform numerous initiatives to communicate the clinical value of Omnipod’s scientific data. This dynamic role will work collaboratively with Clinical and Commercial cross-functional teams to influence corporate strategy and inform the use of Insulet’s line of products to improve the lives of people with diabetes.

The ideal candidate has in-depth knowledge and experience in diabetes and diabetes technologies (e.g., insulin pumps, continuous glucose monitor systems) and has experience interpreting business issues and solving complex problems related to the critical appraisal and dissemination of clinical data according to local regulations. A detailed-oriented and proactive individual with strong scientific acumen, problem-solving skills, and a collaborative spirit will excel in this position.

Responsibilities

Responsible for the development and delivery of medical responses to healthcare providers’ off-label inquiries on a global scale; requiring knowledge of local regulations and customs, translations, and Insulet’s expansive line of products.

Responsible for reviewing the content of global clinical promotional materials to ensure they are medically and scientifically accurate, meet compliance standards, and adhere to all applicable regional regulations and industry guidelines on a global scale.

Responsible for the development and delivery of medical responses to healthcare providers’ off-label inquiries on a global scale; requiring knowledge of local regulations and customs, translations, and Insulet’s expansive line of products.

Responsible for reviewing the content of global clinical promotional materials to ensure they are medically and scientifically accurate, meet compliance standards, and adhere to all applicable regional regulations and industry guidelines on a global scale.

Strategize and inform the development of evidence generation plans to provide meaningful data and impact innovation, support expansion of claims and indications, and satisfy regulatory requirements.

Coordinate the implementation of data management systems with external vendors to ensure compliance standards are met and functionality is optimized.

Develop and execute data dissemination plans to effectively communicate the clinical value of Insulet’s line of products to both internal and external audiences, including healthcare providers, people with diabetes, investors, and regulatory bodies, to emphasize the value of Insulet’s line of products and inform clinical care.

Analyze evidence related to diabetes therapies, standards of care, and technologies to inform product development and commercial and regulatory strategies.

Collaborate with Clinical and Regulatory Affairs on the development of clinical summaries for regional regulatory submissions on a global scale.

Develop clinical quality standards by ensuring procedures reflect current practices and initiatives align with set standards on a global scale.

Strategize and execute plans for International, National, and local scientific conferences (e.g. presentations, reports, medical information booth).

Provide mentorship to Medical Affairs interns.

Key Decision Rights

Responsible for collaborating with cross-functional teams to ensure the clinical value of the Omnipod line of products is communicated internally and externally in a manner that is scientifically accurate, solves unmet needs, and meets global regulatory requirements.

Responsible for interpreting business issues and recommending best practices to ensure the efficient delivery of global off-label information to healthcare providers via the Medical Information channel.

Required Leadership / Interpersonal Skills & Behaviors

Proven leadership skills through the development and management of projects with a cross-functional team.

Works independently, with minimal guidance.

Strong collaborative and cross-cultural skills to work cooperatively between several internal and external teams globally. Creative with a strong desire to innovate and push forward diabetes technologies.

Hands-on, proactive, independent, and self-reliant workstyle

Able to thrive in a fast-paced, multitasking environment and effectively prioritize project timelines.

Self-driven, regularly meets or exceeds expectations.

High ethical standards which apply to interactions with healthcare providers, payers, and industry representatives.

Strong organizational skills and attention to detail demonstrated through the ability to accurately complete tasks within defined timelines.

Able to explain difficult or sensitive information.

Required Skills and Competencies

Proven experience using best practices and knowledge of internal or external business issues to improve products or services.

Experience solving complex problems by taking a new perspective on existing solutions.

Experience with deciphering clinical evidence and translating key points to diverse audiences.

In-depth knowledge and experience of global Medical Affairs best practices related to communicating clinical information externally to healthcare professionals and internally to cross-functional partners is an asset.

Conceptual and practical expertise on diabetes and diabetes technologies (e.g., automated insulin delivery systems and insulin pumps, continuous glucose monitor systems, data management systems) is desirable.

Excellent written and verbal communication skills.

History of strong clinical practice in industry and / or non-industry settings.

Familiarity with global regulatory and healthcare compliance guidelines / policies.

Skilled in medical communication towards diverse audience groups.

Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information data management system, promotional material review)]

Education and Experience

Bachelor’s degree or its foreign equivalent in a health-related field is required. A post-secondary degree (e.g. Masters), healthcare credentials (e.g. RD, RN, PA, NP, PharmD), and / or certification in diabetes education (e.g. CDCES, CDE) is preferred.

Relevant experience in a clinical, industry, or research setting is required (doctorate-level education in lieu of some years of experience is acceptable).

Global experience in the Medical Affairs industry (pharmaceutical / medical device) is preferred.

Clinical or scientific background related to diabetes disease state and diabetes technologies (e.g. insulin pumps, continuous glucose monitors) is desirable.

Fluency in English and German is required.

Additional Information

This position requires some travel up to 15% of the time (domestic and international), but will flex depending on business need.

This position requires hybrid working arrangements at an Insulet office

#LI-Hybrid #LI-JW1

Insulet Corporation (NASDAQ : PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

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