Senior Counsel
Position Overview:
The person in this role will provide expert advice and counseling to the U.S. business on a broad array of strategic and tactical projects within a highly regulated environment. This position will report to the VP, Head of US Legal and Compliance and will be responsible for providing legal support to business partners in various departments across the organization, such as marketing and market research, US sales and sales training, patient support, managed markets, and medical affairs. The ideal candidate will have prior experience counseling prescription drug or medical device companies on legal issues relating to advertising and promotion, scientific exchange, interactions with health care professionals and account teams.
The Company
It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together.
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.
Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.
Key Responsibilities:
Provide Advice and Counsel to Business Partners
· Advise business partners on various business and medical initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation
· Provide legal advice and counsel on advertising and promotion strategies and activities, including: the use of social media; dissemination of scientific information; product development and labeling; pharmacovigilance; product liability; healthcare fraud and abuse; and other matters relevant to the development, manufacture and commercialization of prescription drugs
· Serve as a member of various cross-functional teams
· Stay abreast of and communicate to the organization significant legal developments, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law
· Act as a subject matter expert on matters relating to FDA, CMS/payer laws and regulations and related business operations, staying abreast of evolving legislation and regulations and the enforcement landscape
Contribute to the Legal & Compliance Department
· Work collaboratively with colleagues to develop and implement training to internal business partners on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate business partners about current enforcement trends
· Participate in various Legal & Compliance Department projects and initiatives
· Share information and knowledge through group presentations and individual discussions with peers and managers
· Collaborate with senior contracts manager as needed
Qualifications and Experience:
· JD from an ABA accredited law school
· Member of a state bar (MA or ability to waive in as in-house counsel)
· 8+ years post-JD experience advising on legal matters in a life sciences industry, with at least some time in-house
· Outstanding ability to effectively communicate sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs
· Excellent analytical and problem-solving skills
· Subject matter expert advising on statutes, regulations, and guidance documents applicable to commercial, development 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 documents and advisory opinions; the False Claims Act; and the PhRMA Code
· Experience in supporting pre-commercial to commercial-stage
· Experience serving on a promotional and medical review committee
Personal Attributes
Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who:
· Enjoys working collaboratively and cross-functionally on teams, as well as independently
· Proactively solves problems and makes decisions
· Thrives in a fast-paced and dynamic environment
· Is eager to take on new challenge
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:
- Comprehensive medical coverage
- Dental and vision coverage
- Work / Life balance with core working hours from 10am – 3pm
- Generous paid time-off
- 401(k) retirement plan with competitive company match
- Medical & Dependent Care Flexible Spending Account
- Up to $150 monthly cell phone reimbursement
- Employee Assistance Program
- Free parking
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.
At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.
At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.