The Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking an Assistant General Counsel in the Law Department. The Assistant General Counsel will serve as regulatory counsel and provide both legal counsel and advocacy support along with other members of the Law team on issues relating to the regulation and approval of biopharmaceutical products (e.g. issues relating to reauthorization and implementation of the Prescription Drug User Fees Act (PDUFA), Biosimilar User Fee Act (BsUFA), new drug approval, clinical trials, promotional labeling, post market safety, and manufacturing). The Assistant General Counsel will also provide legal counsel and advocacy relating to the intersection of FDA Law and intellectual property (IP)(e.g., Hatch-Waxman, biosimilars and related exclusivity issues, as well as orphan drug and pediatric exclusivity issues). Specific experience advising biopharmaceutical companies on these issues as well as manufacturing, quality, and supply chain requirements (e.g., GMPs, DSCSA, inspection-related issues) and/or FDA’s regulation of digital health products is preferred.
The Assistant General Counsel will report to the Vice President, Law/Senior Counsel for Biopharmaceutical Regulation, and will work with other PhRMA lawyers working in the relevant subject matter areas.
The Assistant General Counsel will:
- Serve as legal counsel for issues related to the above and assure appropriate collaboration among staff;
- Advocate on behalf of PhRMA and its members on legal and regulatory issues with the US Food and Drug Administration (FDA), Congress, the courts and other law enforcement bodies and government agencies;
- Lead PhRMA’s legal counsel and advocacy on manufacturing and quality-related issues, including GMPs, inspection-related issues, and supply chain considerations;
- Serve as staff lead on PhRMA’s engagement on FDA digital health policies;
- Manage and supervise external counsel and support PhRMA Law team on issues relating to FDA regulatory and intersecting IP issues;
- Provide legal counsel to PhRMA’s Scientific and Regulatory Advocacy Department;
- Provide and coordinate support to federal and state advocacy teams on issues relating to regulatory and IP issues;
- Coordinate legal issue alignment with member company in-house counsel; and
- Provide general legal back-up for PhRMA activity in other substantive areas.
Key Success Factors
PhRMA seeks a collaborative, proactive, self-starter who is passionate about FDA regulatory law and addressing the healthcare challenges we face today. The ideal candidate for this role will be a relationship builder, problem solver and analytical thinker. S/He should have a high level of emotional intelligence, professional presence and the ability to engage others and inspire confidence. Key success factors for this role include intellectual curiosity, strong interpersonal and communication skills, acute political sensitivity and diplomacy and a team focus paired with the ability to work independently. The successful candidate should be adaptable, be able to reprioritize/shift gears quickly and be comfortable in a high-pressure environment.
Professional Experience / Requirements
- JD and member of the DC Bar with at a minimum of 6+ years of experience in a law firm, as counsel in a biopharmaceutical company or trade association or other non-profit or as a public servant in a relevant government department or agency;
- Experience with FDA regulatory law, including FDA related IP issues;
- Exceptional written and verbal communication skills;
- Ability to manage multiple complex high-visibility priorities;
- Ability to communicate legal concepts and opinions to non-lawyers both verbally and in writing;
- Ability to facilitate meetings with, work with and drive consensus among disparate stakeholders; and
- Strong negotiating skills.
Preferred Attributes / Experience
- In-house experience at a biopharmaceutical company, the FDA or Congress
Who we are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested nearly $1 trillion in the search for new treatments and cures, including an estimated $83 billion in 2019 alone.
What we offer
In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD, LTC) and enhanced benefits such as parental leave, a wellbeing program, back-up care, health advocate service, employee assistance program and commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, seven paid holidays (plus inauguration day), half day Fridays preceding holidays and a paid winter break.
We are committed to the growth and development of our team members and offer many learning opportunities including an integrated on-boarding program, best-in-class leadership programming, tuition reimbursement at both the undergraduate and graduate levels, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in organization-wide community service activities, fundraising drives and charitable athletic events.
We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their own personal goals.
Equal Opportunity Employer
As the trade association for several leading biopharmaceutical companies, our workforce and culture should reflect the makeup of our clients and the benefactors of our efforts – patients. We at PhRMA are committed to building a culture where diverse people, ideas, and experiences are welcomed, included, and celebrated; where our employees can thrive as they bring their best authentic selves to work every day. PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing non-discrimination in employment.