Counsel - Digital Innovation Europe

Digitalhealthnews; Berlin; On-site; EUR 70,000 - 100,000; Full time

Job summary

A leading biotechnology company in Berlin seeks a legal Counsel to advise the EU Innovation team on digital health and regulatory issues. Candidates should have a minimum of 5 years of experience in law related to life sciences and demonstrate strong negotiation and communication skills. Fluency in English is required, while German language skills are a plus. The position includes travel opportunities and focuses on implementing novel digital applications related to biopharmaceutical products.

Qualifications

• 5+ years of experience as an attorney in relevant fields.
• Experience in counseling on pharmaceutical and device products.
• Solid transactional and negotiating experience.

Responsibilities

• Advise on legal and regulatory issues for digital health products.
• Support partnerships with healthcare providers and startup enterprises.
• Travel domestically and internationally as needed.

Skills

Counseling on EMA regulations

Interpersonal communication

Research skills

Fluency in English

German language skills

Education

Qualified to practice law in at least one European jurisdiction

Job description

Location: Berlin, Germany Job Type: Full-Time Employer: Amgen The successful candidate will be responsible for advising and supporting the EU Innovation team, including Amgen's Technology Hubs, on a wide variety of issues concerning the development and implementation of novel digital applications and connected solutions relating to Amgen’s biopharmaceutical and medical device products. This position will work closely with the EU Innovation team members at each Technology Hub and other members of the Amgen Law Department. The Counsel will be a member of and report directly to the International Legal Group in Zug, Switzerland. The Counsel will report indirectly to the Strategy & Innovation Law Group in Thousand Oaks, California.

Success in this position will require the ability to counsel, in a fast-paced environment, across a wide range of legal and regulatory issues, including EMA regulation of digital health products and medical devices, software, technology related commercial transactions, co-development, privacy, security, and compliance, as well as provide support for various Business Development opportunities, including various partnerships and collaborations with startup enterprises, healthcare providers and payers.

The role will require domestic and/or international travel.

Qualifications

• Qualification to practice law in at least one European jurisdiction
• 5+ years of experience as an attorney in a large law firm, biopharmaceutical company and/or technology company practicing law related to life sciences/healthcare, digital health or technology
• Experience counseling on EMA regulation of pharmaceutical and device products, including mobile medical applications, connected devices, clinical decision support software and other diagnostic solutions, combination and companion products is strongly preferred
• Strong interpersonal communications, research and writing skills
• Highly developed ability to identify and advise on diverse legal, business, regulatory and compliance issues on a timely basis and to work independently and in a highly collaborative, cross-functional team
• Solid transactional and negotiating experience
• Common sense and good practical business judgment
• Fluency in English
• German language skills a plus

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About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.