US Commercial Counsel

Waltham, MA
Full Time
06-10-2021
Exp.: 10+ Years
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 for Apellis’ investigational and marketed products, and Market Access and Value team.

Responsibilities:
  • Proactively identify and analyze legal risks of Apellis’ investigational and marketed products 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 for Geographic Atrophy and pipeline programs;
  • 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; and
  • Manage legal personnel supporting commercial and medical affairs teams.
  • Lead assigned legal initiatives.

Education, Registration & Certification:
  • D., licensed to practice law in the U.S.; and
  • Active membership and in good standing in a state bar.

Experience:
  • 10+ 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.

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