Global biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases is seeking a an experienced commercial and FDA regulatory lawyer for a dynamic role. This position will provide advice on legal and regulatory issues as they arise in connection with pharmaceutical products, including product development and clinical trials, marketing authorization, manufacturing, distribution, and promotion and advertising compliance.
You will be responsible for reviewing promotional and nonpromotional/scientific materials and strategies, evaluating strategic and tactical commercial/brand and medical affairs plans, clinical educator programs, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, advertising, marketing, product development, product labeling, promotional review, media materials, anti-trust, anti-kickback, competitor issues, market access issues, regulatory policy, medical, pricing, reimbursement, privacy, sales, industry and group company issues and transactional matters. This role will also be responsible for negotiating master services agreements, quality agreements, confidentiality agreements, as well as other corporate agreements.
- Provide strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts and interactions with respect to branded/specialty pharmaceuticals.
- Assist with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development.
- Review promotional materials and tactics including social media and healthcare professional and consumer-directed advertising as well as nonpromotional/scientific pieces and scientific exchange materials. Participate in review committee meetings.
- Provide product support counseling for one or more of the company’s products/product candidates from development through commercialization and lifecycle planning
- Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate and advise on label and approval challenges
- Provide regulatory environment updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products
- Assist in preparing clinical trial documentation, including investigator agreements and informed consent forms
- Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments
- Partner and collaborate with other departments and functions (e.g. HR, IT, Clinical Operations, Market Access)
- Serve on other cross functional teams and governance bodies as assigned
- Prepare and Conduct training on a variety of legal and compliance topics
- Assist in the preparation of organization and leadership communications
- Supervise outside counsel
Skills / Ideal Candidate:
- Excellent oral and written communication skills; strong presentation skills, with the ability to communicate abstract ideas and legal advice to executive and senior management as well as non-legal colleagues and non-native English speakers.
- Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to the company.
- Strategic, analytical thinker and creative problem solver who possesses innovation, client management, demand management skills and regulatory knowledge.
- Strong organizational skills with the ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously.
- Energetic self‐starter with demonstrated influencing skills and a results orientation. Must be able to quickly gain the trust and respect of senior executives, peers and clients.
- Ability to work both in a strategic big picture mode, as well as tactically, including the capability to “roll up one’s sleeves” and work in detail.
- Flexible, and possessing a commercial, business focus in approaching this position.
- Work well independently, while meeting aggressive deadlines and prioritizing multiple matters
- Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions
- Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting the company’s interests
- Juris Doctorate (J.D.) degree from a nationally recognized law school.
- Admitted to the Bar (and current good standing with) of at least one state or the District of Columbia and eligible for admission to the New Jersey Bar as in-house counsel.
- At least 5-10 years of experience in a healthcare law role in the biotechnology / pharmaceutical industry, with significant experience supporting branded biotech/pharmaceutical product(s), including participation in promotional and medical review processes. Both in house and major law firm experience preferred. Must preferably have experience applying FDA law and regulation across strategic counseling matters, investigations, and corporate transactions involving FDA-regulated companies.
- Technical background an asset for supporting technical operations and quality assurance.