Associate Senior Counsel, Commercial & Medical Affairs

POSITION ID: REG1308
CATEGORY:
PRACTICE AREA: , , ,
LOCATION: New Jersey
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Global Pharmaceutical company in Northern New Jersey is seeking an experienced commercial and regulatory lawyer.

JOB SUMMARY

The successful candidate will be primarily responsible for providing counsel specific to the company’s pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other medical activities, monitoring, co-promotions, and FDA standards for a variety of pipeline and in-line oncology assets.

Essential Functions

1. Provides proactive and day-to-day legal support, advice and counsel on a variety of commercial and medical matters relating to assigned products, including promotional and medical affairs materials, labeling, sales training and media/digital materials.

2. Works to ensure the company’s compliance with pharmaceutical laws including the Anti-Kickback Statute, False Claims Act, PhRMA Code and FDA regulatory guidelines.

3. Serves as the legal representative on promotional and scientific review committees.

4. Manages the legal and reputational risks of assigned business clients.

5. Helps drive the implementation of legal strategy and policies.

6. Develops training content as needed on legal and other risks.

REQUIREMENTS

· JD degree and 7+ years of legal practice including a minimum of 4 years focused on providing counsel to the pharmaceutical industry.

· Member in good standing of a state bar.

· Strong knowledge of FDA regulatory and fraud and abuse law.

· Ability to learn quickly and operate in a fast paced, matrixed environment

· Able to participate on key teams and/or be involved in key projects.

· Excellent level of oral and written communication skills, able to effectively present ideas, counsel and information to others.

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