Senior Legal Counsel managing diverse legal responsibilities at M - Files. Supporting global business operations while ensuring compliance and managing legal risk within a hybrid work environment.
About the role
- Assistant General Counsel providing legal advice on biopharmaceutical commercialization. Focus on promotional review and compliance with US healthcare laws and regulations.
Responsibilities
- Serve as the legal representative on the promotional review committee for Brand team.
- Provide legal advice to Brand team on relevant laws, regulations, and rules regarding promotional, advertising, HCP engagements and communications in relation to commercialization of biopharmaceutical products, marketed and investigational, including but not limited to the Food, Drug and Cosmetic Act; and implementing regulations promulgated by the FDA pertaining to drug labeling and the advertising and promotion of pharmaceutical products.
- Draft, negotiate and review agreements to support the Brand team, including healthcare professional consulting agreements, vendor agreements, and service agreements as delegated by legal contracts process.
- Ensure that Brand team operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations.
- Support Global Medical contracts (US HCPs)
- Support US Grant contracts approved by the Grants Review Committee
- Support US Sponsorship contracts approved by the Sponsorships committee
- And other job duties that may be assigned. May be modified at any time as business needs require.
Requirements
- BA or BS from a recognized college or university.
- JD degree from an accredited law school.
- Admitted to practice law in at least one U.S. jurisdiction.
- Minimum of 8+ years of experience in advertising, promotion, and commercialization of products at a pharmaceutical company or law firm.
- Excellent verbal and written communication skills.
- Thrives on building relationships and providing support and training.
- Ability to actively participate in [brand team] meetings and productively add value to group dynamics and group discussions and propose pragmatic solutions or alternatives in real time.
- Possess the ability to recognize risks and the ability to think of workable strategies to mitigate such risks.
- Strong negotiation skills.
- Strong strategic thinking skills and ability to translate strategy into an effective action plan.
- Be a team player who is collaborative and resourceful.
- Ability to travel up to 20% of the time domestically and internationally.
Benefits
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of Pet Insurance and Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account (HSA)
- Flexible Spending Accounts
- Various incentive compensation plans
- Accident, Critical Illness, and Hospital Indemnity Insurance
- Mental Health resources
- Paid leave benefits for new parents
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