US Commercial Counsel

Legal Waltham, Massachusetts


Description

Position Summary:

The US Commercial Counsel is a key member of our legal team who will primarily support the commercial and medical affairs functions.

Responsibilities:

  • Proactively identify and analyze legal risks on the US launch of Apellis’s product based on applicable laws and regulations (Anti-kickback, False Claims Act).
  • Serve as legal advisor to commercial, medical affairs, market access and patient services teams for late stage and marketed products.
  • Serve as lead lawyer on cross-functional product review committees.
  • Provide high quality legal advice and counsel on advertising and promotional messaging, materials, and activities; speaker program materials and training; the dissemination of scientific communications; non-promotional disease awareness materials; patient assistance materials, programs and resources; payor marketing materials; and advisory board materials.
  • Advise business colleagues on interactions with key customer stakeholders, including patients, physicians, payors, and specialty pharmacies.
  • Review business materials (including brand plans, medical plans, training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant and appropriate strategies, plans and tactics.
  • Draft and negotiate a range of agreements, including product purchase, discount and rebate, data purchase, and patient hub services.
  • Assist and/or supervise other department personnel in the negotiation and drafting of agreements with healthcare providers, patients, grants, sponsorships and charitable donations.
  • Work collaboratively with Compliance to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance; keep abreast of current enforcement trends and educate clients and partners accordingly.
  • Become a trusted, go-to legal advisor that advances the company’s overall mission and goals while identifying and mitigating legal risks and the company’s reputation.
  • Lead assigned legal initiatives.

Education, Registration & Certification:

  • J.D., licensed to practice law in the U.S.; and
  • Active membership and in good standing in a state bar.

Experience:

  • 6-8+ years of post-JD experience, preferably including both law firm and in-house in pharmaceutical industry.
  • Experience advising on statutes, regulations and laws relevant to the commercialization of pharmaceutical products, including False Claims Act; FDCA, FDA promotion and labeling; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; U.S. transparency laws; anti-bribery laws, and other laws and regulations related to the commercialization of pharmaceutical products.
  • Experience supporting a pharmaceutical commercialized brand is highly desired.
  • Excellent oral and written skills.
  • Self-motivated, strong leadership, work well independently on projects, meet aggressive deadlines, handle multiple projects, technical knowledge, business acumen, and excellent communication skills.
  • Sound conflict resolution skills and ability to work in a collaborative, global environment.
  • Effective decision making; proven ability to assess and calibrate and effectively communicate legal risks to senior management and others.

Skills, Knowledge & Abilities:

  • Problem solver with sound business judgment.
  • Decisive with strong sense of corporate responsibility.
  • Willing and able to take initiative.
  • Demonstrated organizational skills.
  • Strong interpersonal and communication skills.
  • Ability to work with different levels of management and collaboratively with teams.
  • Highly motivated with the ability to be flexible in a fast-paced environment.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

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EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.