Vice President, Legal (Commercial Operations, Compliance) – NC Pharma/Will Relo
Our client, a Raleigh area pharmaceutical company experiencing exponential growth, is actively recruiting for a very sharp, knowledgeable and skilled corporate attorney to oversee all legal matters for the firm. This position will report to the Chief Operating Officer. Strengths in Commercial Operations and Regulatory Compliance will be essential.
Company will pay industry-leading wage, including relo support, to attract and retain an excellent candidate.
Key Things to Note:
- This company has multiple marketed products, recently completed a major acquisition and is in the midst of two product launches. It is essential that the right policies and practices are in place to ensure compliance, legal excellence and optimal risk management. This VP will drive that effort.
- Primary responsibilities will focus on commercial compliance including FDA promotional matters commercial, quality & R&D contracts, healthcare fraud and abuse, market access programs, etc. Substantial knowledge of FDA and state/local regulations as well as commercial best practices will be essential.
- This company outsources many R&D and commercial functions. Significant experience drafting and reviewing related contracts will be important.
- This VP will supervise the Compliance team which oversees compliance with state law programs, aggregate spend, etc. as well as sales force training, investigations, review processes (e.g. PDMA, OIG, AdvaMed), etc. Seek seasoned supervisor of people with expertise in all of these functions.
- This VP will interface with a high expectations and varied constituency. Seek candidate with outstanding communication skills and the demonstrated ability to garner the trust and respect of internal and external partners.
- This is an emerging company in a high growth phase. Right candidate will complement substantial legal expertise and know-how with a hands-on, get-things-done work style.
This VP, Legal Counsel will be responsible for providing legal advice and support of company products including pipeline and commercial products as well as Medical Affairs functions. S/he will work collaborate with Regulatory, R&D, Supply Chain, Quality, Sales and Marketing, etc. and guide leaders towards smart and compliant choices.
- Provide legal direction on FDA promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products.
- Counsel on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities. Ensure Sales, Marketing and Medical Affairs teams are educated on best practices.
- Draft, review, negotiate and interpret commercial, R&D, master service and consulting agreements, licensing and research collaborations, and other strategic alliances for quality assurance, drug development, clinical manufacture, supply chain, and market access (including government and payer drug rebate agreements, affordability programs, etc.).
- Supervise the Compliance Team that oversee internal compliance matters, including employee training on commercial best practices.
- Serve as the legal representative on Promotional Review Committee
- Advise on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies.
- Advise Executive Management regarding risk mitigation pertaining to business and marketing activities, litigation matters, and special projects/events. Collaborate with commercial, corporate communications and the Medical Affairs teams regarding communications with customers and media.
- Collaborate across global Legal Department as necessary to support business clients/practice area.
The right candidate will be licensed attorney with substantial experience (5+ years) handling directly-related commercial matters within the pharmaceutical industry. Inside corporate counsel bkgd within an emerging pharma is preferred but will also consider highly capable, knowledgeable and industrious candidates from pharma law firm practices.
Other priorities include:
- Exceptional knowledge of FDA and state requirements, industry practices and relevant case law
- Extensive experience drafting and reviewing commercial contracts including Supply Chain, Quality, R&D, Market Access, etc.
- Substantial experience overseeing commercial compliance. Team supervisory experience required.
- Experience serving on a Promotional Review Committee
- Longevity and impact in previous roles
Finally, we seek a business savvy and influential communicator with the demonstrated ability to convey to leadership the legal implications, risk mitigators and alternate paths available to lead them to optimal choices.
This is an immediate need. Please forward Word resume for prompt communication.