The Brand Counsel position reports to the Lead Brand Counsel and is a full time exempt position located at our Malvern, PA or New York, NY location.
The Brand Counsel position will be primarily responsible for providing advice and counsel on regulatory, compliance and commercial issues. The position will collaborate with internal clients at all levels and requires the ability to work confidently, proactively and assertively with a high level of independence. The position requires an individual who can work in new subject matter areas on a daily basis and to assimilate information quickly and develop expertise in those areas.
Duties include providing legal advice related to the development and distribution of FDA regulated medical devices predominantly in the US; review of a high volume of promotional content for sales and marketing and other content for healthcare professionals, patients, and managed care organizations as well as internal/external training and similar material; routine counseling on healthcare compliance issues including close interaction with the Compliance function and the marketing and sales organization; and providing support to general legal needs of the company, such as drafting and negotiating contracts in support of the business. The Brand Counsel will have primary responsibility for one of the in-market brands in the US as well as responsibility for some of the future pipeline indications.
It is expected that the Brand Counsel will travel frequently (up to 25% of time) (i) between company’s offices in the United States (Malvern, PA; NY, NY; Portsmouth, NH); (ii) to observe field staff; and (iii) to perform effectively the duties of the Brand Counsel. The Brand Counsel will report to the company’s Lead Brand Counsel.
Essential Duties and Responsibilities:
Marketing Materials review product labeling/marketing materials for compliance with FDA requirements
Health Care Professional Interactions collaborate with Compliance, Commercial and Medical Affairs team members to create solutions for developing compliant relationships with healthcare professionals and government officials
Regulatory and Clinical Affairs provide counsel on FDA regulatory matters for medical devices
General Contracts prepare, negotiate and review a wide variety of contracts including, clinical trial, registry, research and consulting agreements, software licenses, NDAs, product design and manufacturing agreements, distributor agreements (structure and negotiate incentive programs), etc.
Compliance’ work closely with the Compliance fuction and collaborate with compliance to implement policies and procedures to ensure compliance with government and industry initiatives and regulations (legal/ethics requirements for medical device manufacturers, anti-kickback law, anti-trust issues, anti-bribery, etc.)
Training’providing training on a wide range of issues related to labeling and promotional content, reimbursement, best practices, FDA regulatory issues, etc.Qualifications and Skills:
JD and admission to PA bar (or eligible for PA in-house counsel license)
Minimum 5-7 years of relevant legal experience as a corporate/commercial attorney, preferably in a midsize to large law firm or other relevant in-house experience
Minimum 3 years of healthcare industry experience
Legal counsel and medical device or prescription drug experience including experience with regulatory approval process, counseling active clinical/medical affairs organizations
Prior experience as a legal reviewer on a US promotional review committee
Experience working with and advising Medical Affairs
Understanding of Medicare regulations
Strong understanding of general healthcare laws including those involving fraud & abuse
Ability to actively work to identify, analyze and mitigate potential risks to the organization
Prior experience supporting a product launch highly preferred
HIPAA and data privacy experience preferred
Salary/title will be commensurate with experience.
Must be eligible to work in the U.S.
Ability to lift 15 pounds
Local candidates only, no relocation assistance provided