Join the World's Top Legal Talent Network

Introduction/Purpose

At Sobi, parent company of Dova, we are transforming the lives of people affected by rare diseases. As a specialized international biopharmaceutical company, we provide sustainable access to innovative therapies in the areas of haematology, immunology and specialty care. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving.

IMAGINE the next step in your career journey! If you are ready to upend the status quo, come join us!

The Associate General Counsel North America will advise business partners on various Commercial and Medical initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation. You will provide focused legal support for marketed rare and specialty disease products in North America, across their lifecycle development. You will act as a subject matter expert on matters relating to healthcare law and related business operations, staying abreast of evolving healthcare legislation and regulations and the enforcement landscape in order to provide sound legal advice on matters including advertising and promotion strategies and activities, dissemination of scientific information; product development and labeling; market access initiatives; healthcare fraud and abuse; and, other matters relevant to the development, manufacturing and commercialization of prescription drugs. You will be a key member of both the North America and Global Legal Affairs teams.

Essential Responsibilities/Scope of the Job

• 
  Serve as legal advisor and lead brand attorney to sales, marketing, medical affairs, market access, distribution and product development teams for marketed rare and specialty disease product(s) in North America (both US and Canada)
• Serve as lead lawyer on cross-functional teams including without limitation, franchise/brand teams, promotional and scientific material review committees, launch teams, and applicable global teams as required
• Review business materials (including brand plans, medical plans, strategic initiatives, training documents) requiring legal input and advise internal clients, partners and stakeholders on compliant strategies, plans and tactics
• Partner with internal clients to identify and understand their business requirements, and negotiate contracts in accordance with those requirements and the company’s overall objectives, priorities and policies
• Draft and negotiate various agreements, to include commercial, distribution, supply chain, managed markets, advertising, licensing, collaboration, grant, sponsored research, clinical trial agreements, speaker, consultant and BD-related agreements.
• Liaise with colleagues at Sobi’s global headquarters in Sweden on legal matters related to commercial and scientific support of the product, including product development and strategy
• Support across all stages of the product’s lifecycle, including advising cross-functional teams comprised of research & development, medical & scientific affairs, regulatory, and other clients on FDA regulatory strategy, submissions, and label negotiations
• Counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, academic institutions, and payors
• Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends
• Manage outside counsel

Position Qualifications (knowledge, skills, abilities, education, experience)

Education & Experience

• 
  J.D., licensed to practice law in the U.S.
• Active membership and in good standing in a state bar
• Minimum of 7 years post-JD experience, preferably including both in a law firm and in-house in the biopharmaceutical industry
• Experience supporting commercialized rare and/or specialty disease product(s) as cross-functional legal lead strongly preferred
• Strong knowledge of and experience advising on statutes, regulations, and guidance documents applicable to commercial operations and medical affairs activities, including: research and interpretation of the Food, Drug, and Cosmetic Act; FDA regulations and guidance; federal and state anti-kickback statutes; OIG guidance document and advisory opinions; the False Claims Act; the Sunshine Act; and the PhRMA Code

Competencies

• Excellent oral and written skills
• Outstanding ability to effectively communicate sound legal advice to lawyers and non-lawyers alike, coupled with a strong business acumen and understanding of business needs and functional roles/responsibilities
• Self-motivated, work well independently on projects, meet aggressive deadlines, handle multiple projects successfully in a constantly changing, fast-paced environment
• Sound conflict resolution skills and experience in navigating successfully in a highly matrixed global work environment
• Strong collaborator and team player
• Strong leadership skills, high integrity, strong work ethic, respectful and conscientious
• Must be able to effectively and fluidly straddle between responding to and executing on day-to-day tactical responsibilities and implementing strategic imperatives that will move the organization forward

This is an office-based job and will include approximately 15-20% travel (both domestic and international).

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

With a deeply skilled management team directing our day-to-day wins, we’re ready to take on the world’s diseases, ailments, and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, then we just may have a great job for you!

We know our employees are our most valuable asset, and our culture conveys that. We also offer a competitive benefits package to support the health and happiness of our staff.

An Equal Opportunity Employer

Dova is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Dova are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, veteran status, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

bLFEm89OdW