Associate Director, Regional Compliance
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Seagen commercializes a medicinal product for metastatic breast cancer and focuses on improving the lives of people with cancer through innovative targeted therapies. We have been building our infrastructure and our operations in Europe and internationally, which include a group of 11 operating Affiliates located in the following countries: Italy, France, Spain, Denmark, Sweden, UK, Netherlands, Germany, Austria, Switzerland and Canada, and partnered markets outside of core Europe. As we continue to grow at a rapid pace, new and exciting opportunities open up for experienced professionals. When considering candidates, we look for professionals who are collaborative, highly motivated, and who share our passion to help cancer patients. In this context, we are seeking a Healthcare Compliance professional with very strong pharmaceutical/biotech industry experience.
The ideal candidate has proven experience in Healthcare Compliance in more than one of the jurisdictions of interest, including Canada, and is able to oversee the development of a regional compliance program strategically, but also to manage day to day requests from individual countries, advising on the most compliant path forward taking into account local specificities. As Associate Director Regional Compliance you will be responsible for assisting all business functions and for providing support to the international colleagues at regional and country level in Commercial, Market Access, Medical Affairs and other departments, as need may be.
Reporting to Legal & Compliance International, you will drive all the aspects of the Seagen international Compliance Program and help install and grow the position at country level as needed. You will be a member of the Legal and Compliance team, with great chances of developing your career path in a very dynamic and fast-growing organization.
Topics like the difference between a sponsorship and a grant, how to do transfer of vale transparency reporting, why it's important to firewall information in sections of a CRM, how to build a compliant sales force incentive plan are your thing! The Associate Director Regional Compliance will be exposed to and collaborate with various functions based in our global HQ in Bothell, Washington, USA. This position may be based in any of the following countries: Switzerland, Germany, Italy or the UK (see our locations at https://www.seagen.com/contact).
The position will support with building the Seagen international compliance program and will have significant interactions with the Medical, Commercial, Finance, Development and HR departments as well as other company departments. The Associate Director Regional Compliance will work closely with Global and Affiliate teams to drive the development and implementation of the European policies and SOPs related to interactions with healthcare professionals and healthcare organizations, patients and patient organizations and other healthcare compliance topics, as well as ensuring the provision of related training content and subject matter expertise. As a key interface for the Compliance function, the Associate Director Regional Compliance will also contribute to the development of the global monitoring and audit programs.
Main responsibilities include:
- Drive the development of the pillars elements of an effective compliance program, leveraging knowledge of industry best practices
- Represent to point of contact for day-to-day compliance questions from the assigned cluster of countries
- Proactively plan for emerging trends in Compliance, anticipate the impact on processes, and work with the Compliance leadership and the business stakeholders to determine how to address them using the most up to date information around emerging compliance trends
- Advise and provide support to business functions to maintain an internal infrastructure that supports a culture of compliance and recognizes that compliance is a collective responsibility of all employees
- Establish strong relationships with key internal stakeholders to understand current and future compliance needs
- Provide guidance to the Business and integrate compliance controls into the scope of existing business practices where applicable
- Create, oversee or conduct in-person and/or web-based compliance trainings for field forces and general employees
- Partner with Compliance Investigations regarding potential violations of compliance policies, laws or regulations and oversee corrective actions with business function.
- Advise and/or review of promotional and non-promotional materials to be disseminated in the region
- Advising and/or coordinate legal advice on advertising and promotional laws, data privacy, anticorruption, and labor law in connection with Compliance matters for the given cluster of countries
- 4-6 years of recent, relevant in-house experience in a pharmaceutical or biotechnology company’s Compliance department
- Proven expertise in healthcare Compliance in multiple jurisdictions among those where Seagen has core operations (Italy, France, Spain, Nordics, UK and Ireland, Netherlands, Belgium, Germany, Austria, Switzerland and Canada)
- Comfortable working in a fast-pace growing company: a hands-on, roll-up-the-sleeves approach will be essential. Strong focus on operational and strategic skills is required
- Extremely resourceful and smart individual, problem-solver and self-starter, with the appetite to deliver results while dealing with ambiguity
- Genuine care for patients and desire to make a meaningful difference in their lives.
- Convinced and ambassador of the Company Values (Passion for helping patients; Integrity; Scientific excellence; Teamwork and mutual respect; Innovation; Great work environment).
- Experience working in affiliate and/or cross regional roles is required
- Strong collaborative skills and the ability to thrive in a science-driven organization and able to convey complex concepts and strategies, orally and in writing
- Excellent listening skills; seek broad input and feedback
- Must be a well-organized, high energy, detail oriented, and persistent team player with the ability to identify / focus on key issues, prioritize efforts, and ensure follow up with timely / quality results
- Fluency in English with the ability to communicate in both verbal and written form with multiple stakeholders within and outside the company; additional fluency in other European languages a plus
- Knowledge of and experience with European laws, regulations, industry codes and guidance that affect the pharmaceutical industry
- Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with input from multiple stakeholders
- Ability to travel as necessary within the Region and to the Swiss HQ
- Law degree and qualification as attorney at law preferred
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.