The current opening is an excellent opportunity to learn and grow as an attorney and contributing member of a team focused on improved patient care. The person filling this position needs to rapidly advance to being the primary back-up to Amarin’s Chief Pharmaceutical Compliance Officer on promotional review, training and auditing. This person is expected to be able to assume lead roles in addressing various matters from the start and to learn at a rapid pace as needed both to fill the requirements of the job and to match the evolving challenges of a growing company.
The successful candidate will be substantially knowledgeable and experienced in laws and regulations that apply to developing and commercializing pharmaceutical products. The candidate's primary focus will be on U.S. matters but the candidate needs also to be able to research and address solutions to international matters as needed.
The successful candidate must be independent, self-sufficient, and proactive with leadership abilities. The individual must have a demonstrated ability to work accurately and effectively in a fast-paced, high pressure environment, without routine supervision. Effective interpersonal skills, including ability to be persuasive and to deal with a broad range of people are essential. Good presentation and organizational skills are required to succeed.
This position has 5 major job responsibilities. Each responsibility must be handled as expeditiously as possible. Each of these responsibilities is important such that the order of presentation below is not intended to suggest a prioritization of such responsibilities:
Perform compliance monitoring and auditing activities.
Conduct vendor audits
Prepare audit reports
Perform field ride-alongs
Monitor speaker program compliance nationwide for Amarin product(s)
Help establish appropriate frequency and targeting of such audits and develop remediation plans, if and when needed
In conjunction with the Chief Pharmaceutical Compliance Officer, support the promotional review committee, specifically including assessment of and reasoned input on regulatory/legal matters to promotional and commercial materials and associated claims and activities. This includes:
Participate at promotional review committee providing needed regulatory and legal input. Provide proactive opinions use influencing skills as a prelude to requiring the opinion be followed
Have a broad enough experience in review matters to be prepared with on-the-spot legal/regulatory/policy dictated opinions and, when needed, help to find effective solutions
Provide counsel on concepts including marketing, medical and others that may eventually come to the promotional review committee
Provide regulatory advice including review of contracts
Research, author, and conduct training on matters related to compliance and corporate policy
Excellent research, writing and editing skills to author SOPs
Full understanding of how to translate SOPs into training for comprehension and understanding across all levels of the organization
Perform other tasks as directed by the VP Compliance and VP, Patents
Education/Training: JD required with bachelor’s degree, preferably with a science background. A minimum of 3 to 8+ years’ experience with US FDA issues, including (1) review of promotional items, (2) AKB including copay card issues, (3) clinical/research issues such as FDA compliance audits of clinical sites, (4) auditing for compliance of field sales personnel, (5) authoring SOPs, training, and other instructional documents, (6) pharmaceutical compliance and regulatory issues, and (7) various types of contracts.
Knowledge and Abilities: To be successful the candidate must be able to work rapidly, accurately, and efficiently in a high-paced, fast environment. The candidate must have a broad understanding of the FDA and state regulations of pharmaceutical companies. It is critical that the incumbent have the ability to distill complex materials into understandable, comprehensible training. An in-depth knowledge and understanding of regulatory and legal requirements of promotional claims, medical and scientific education, and non-promotional activities is essential. The successful candidate must have the ability to interpret those requirements in such a way as to ensure compliance during review of proposed new promotional materials. It is essential that the individual be fluent in the requirements such that assessments and unambiguous recommendations can successfully be made in a fast-paced entrepreneurial setting. The candidate will conduct compliance audits requiring the ability to accurately identify problems on-the-spot and work to rapidly implement effective, compliant solutions. The individual must have the ability to exercise good judgment in interpretation of company policies. And, the successful candidate must be a person of high integrity, who treats people fairly and consistently and who maintains confidentiality of sensitive information when appropriate.
Skills: Excellent communication and interpersonal skills. Ability to work well in a team, pitch in and assist others as needed. The candidate must be willing to learn and able to handle multiple matters of a diverse nature in any day. It is essential that the candidate be proficient in general computer applications, such as MS Word, Excel, and Powerpoint and have the ability and interest in learning new applications as needed. Must be a skilled and expeditious proof reader of a variety of legal, technical, and other documents.
Additional Salary Information: 18 days PTO; annual bonus and equity
About Amarin Pharma Inc
: Amarin Corporation plc (Nasdaq: AMRN), is a multinational biopharmaceutical company focused on commercialization and development of therapeutics to improve cardiovascular health with initial focus on lipid management, a complex and emerging field.
Amarin’s drug, Vascepa® (icosapent ethyl), is in the early stages of commercialization with growing U.S. revenue of $180 million. Vascepa is also in the late stage of a cardiovascular outcomes study designed to determine the drug’s effects on cardiovascular risk reduction in a high risk patient population after statin therapy, an unmet need for millions of patients, and a potential multi-billion dollar opportunity for Amarin. Vascepa has been shown in two phase 3 trials to lower triglycerides and have other favorable effects on other markers of cardiovascular risk, with a safety profile comparable to placebo. Amarin markets and sells Vascepa directly in the United States and has begun licensing Vascepa for international development, with collaboration partners in place in China and the Middle East and Canada. Plans are underway for significantly expanding Amarin’s promotion of Vascepa while increasingly evaluating other product oppor...tunities.
Amarin is headquartered in Dublin, Ireland. In the U.S., the company's office is in Bedminster, New Jersey. For additional information, please visit www.amarincorp.com.
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