Senior Director, Legal, Corporate Counsel, Market Access

BioMarin Pharmaceutical Inc

San Rafael, CA

JOB DETAILS
SALARY
$232,000–$319,000 Per Year
SKILLS
Administrative Skills, Adverse Events, Alliance/Partner Marketing, Analysis Skills, Antitrust, Biology, Biotech and Pharmaceutical, Brand Strategy, Budgeting, Business Operations, Business Plan, Clinical Data, Clinical Trial, Communication Skills, Compensation Management, Compensation and Benefits, Contract Negotiation, Corporate Policies, Cross-Functional, Disease, Distribution Channel, Distribution Services, Facebook, Federal Laws and Regulations, Fellowship, Genetics, Government, Government Contracts, Government Reporting, Health Economics, Healthcare, Healthcare Providers, Human Resources, Leadership, Legal, Legal Reports, Legal Support Skills, License Agreements, LinkedIn, Maintain Compliance, Manufacturing, Medicaid, Medical Products, Medical Records, Medicare, Needs Assessment, Negotiation Skills, Network Integration, Newsroom, Operations Planning, Organizational Skills, Patient Care, People Management, Pharmacy, Prescription Drugs, Press Releases, Pricing, Pro Bono, Problem Solving Skills, Product/Service Launch, Publications, Purchasing/Procurement, Recruiting/Staffing Agency, Regulations, Regulatory Compliance, Reimbursement, Reporting Skills, Space Science, State Laws and Regulations, Statutory Laws, Strategic Planning, Supply Chain, Team Player, Technical Leadership
LOCATION
San Rafael, CA
POSTED
5 days ago

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n BioMarin Pharmaceuticaln

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Senior Director, Legal, Corporate Counsel, Market Access

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Location: San Rafael, United States

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Workstyle: Hybrid

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Who We Are

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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

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Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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About Corporate Groups

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It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

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This role provides expert Legal advice to the business on a wide range of activities within a highly regulated environment. This role is responsible for providing legal support to the Market Access function within BioMarin, including Pricing, Access, Value, and Evidence which supports, Managed Markets, Pricing, Government Pricing, Patient Support and related functions. The ideal candidate will have prior experience counseling prescription drug companies on legal issues relating to market access, government pricing, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency patient assistance, brand strategy and product commercialization activities.

Key Responsibilities

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  • Advise business partners on various Commercial initiatives in a way that advances the companyxe2x80x99s strategy while addressing legal risks and protecting the companyxe2x80x99s integrity and reputation n
  • Provide legal advice and counsel on: n

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  • Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act n
  • Market access and reimbursement issues n
  • Government pricing, including price reporting compliance policies and reasonable assumptions documents n
  • Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance n
  • Proposed and enacted United States federal and state legislation impacting pharmaceutical companies relating to market access, pricing, reimbursement as well as state drug price reporting and transparency laws and compliance n
  • Services and contracting relating to specialty distributors and specialty pharmacies n
  • Data and special projects n
  • Brand strategic planning and business operation plans n
  • Staying abreast of evolving healthcare legislation and regulations and the enforcement landscape n

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  • Provide legal counsel and strategic support for the development, negotiation, interpretation, and administration of a broad range of pharmaceutical commercial contracts and arrangements with customers including: n

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  • Commercial and government payers n
  • Pharmacy Benefit Managers (PBMs) n
  • Group Purchasing Organizations (GPOs) n
  • Specialty pharmacies and distributors n
  • Wholesalers and distribution partners n
  • Integrated Delivery Networks (IDNs) n
  • Health systems and provider organizations n
  • Patient support and patient services vendors n

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  • Review, draft, and negotiate rebate agreements, value-based and outcomes-based agreements, administrative service agreements, distribution agreements, data licensing agreements, patient support agreements, and other market access-related contracts. n
  • Ensure compliance with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations n
  • Collaborate with Legal and Compliance colleagues to ensure delivery of comprehensive legal advice n
  • Participate in Medical Legal Review to provide guidance regarding external messaging n
  • Review and counsel on product labeling, promotional claims, comparative claims, health economic information, scientific exchange activities, and communications regarding clinical data, as necessary n
  • Contribute to the Legal & Compliance Department n
  • Participate in various Legal & Compliance Department projects and initiatives, including committees such as Culture and Pro Bono & Community n
  • Share information and knowledge through group presentations and individual discussions with peers and managers n

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Qualifications, Professional Skills, and Preferred Experience

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  • JD from an ABA accredited law school n
  • Member of a state bar n
  • Minimum of 8 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or both n
  • Government price reporting experience n
  • Familiarity with health economic and outcomes research (HEOR), value communications, and market access promotional considerations is preferred. n
  • Strong ability to provide practical, business-oriented legal advice in a highly regulated environment while balancing legal, regulatory, reputational, and commercial considerations. n
  • Experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA Code n
  • Significant experience advising on pharmaceutical customer contracting across a broad range of stakeholders, including commercial and government payers, Pharmacy Benefit Managers (PBMs), Group Purchasing Organizations (GPOs), specialty pharmacies, specialty distributors, wholesalers, Integrated Delivery Networks (IDNs), and healthcare providers. n
  • Demonstrated experience drafting, reviewing, negotiating, and counseling on complex market access, rebate, distribution, administrative services, data, patient support, and value-based contracting arrangements. n
  • Outstanding ability to effectively communicate (verbally and in writing), sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs n
  • Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards n
  • Ability to effectively and efficiently manage outside counsel and adhere to a budget n
  • Experience providing legal advice on specialty medicines is highly desired n
  • Enjoys working collaboratively and cross-functionally on teams, as well as independently n
  • Proactively solves problems and makes decisions with integrity and ethics n
  • Thrives in a fast-paced and dynamic environment n
  • Is eager to take on new challenges n

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Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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Equal Opportunity Employer/Veterans/Disabled

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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The salary range for this position is: $232,000 to $319,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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About the Company

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BioMarin Pharmaceutical Inc