Associate Director, Brand Counsel - Tandym

A global biopharmaceutical company is seeking an Associate Director, Brand Counsel, to join their team. The Associate Director, Brand Counsel will provide legal support and review of materials for commercial and medical affairs activities related to the organization's product.

*This position is 100% remote but requires candidates to work east coast hours.

Responsibilities:

• Develop a thorough understanding of and familiarity with the company's business, its people, in-line rare disease respiratory product and disease state, markets, facilities, customers and competitors and utilizes that knowledge in providing guidance and counsel to internal clients.
• Establish a rapport and a working relationship with commercial and medical leaders and team members at all levels to encourage and continue the proactive engagement with in-house legal counsel.
• Provide legal advice and conduct review of commercial team initiatives supporting commercial expansion upon completion of Phase 3 confirmatory study related to the company's product with a primary focus on the anti-kickback statute, false claims act and advertising and promotional regulations.
• Review promotional and field medical materials and associated strategies for compliance with applicable guidance, laws and regulations and serve as primary legal member on the applicable review committees.
• Collaborate with cross-functional partners and Legal team members supporting Franchise and pipeline products to deliver aligned and timely guidance to applicable teams.
• Review and provide advice on corporate communication and product communications and related internal and external activities and materials.
• Serve as contract review escalation point for related commercial and corporate communications contracts ensuring alignment with company standards and compliance with applicable laws and industry standards.
• Identify and communicate to clients risks associated with day-to-day operational business activities, including training clients on applicable legal issues within lawyer's expertise.
• Partner with clients to proactively apply legal and regulatory framework to business activity by understanding business goals and developing alternative solutions to assist in the achievement of successful outcomes.
• Negotiate on behalf of, and partners with, clients to achieve solutions consistent with business objectives.
• Builds constructive working relationships with client base and operates as an active member of legal and client teams.
• Coordinates legal matters handled by outside counsel.
• Other duties and responsibilities, as assigned.

Knowledge & Experience:

• Experience in promotional and non-promotional review, regulatory matters, risk management and contract management.
• Experience in contract, business, FDA, and drug laws and regulations specific to the life science industry.
• Ability to identify, strategize and respond to a broad range of issues related to business, operations and risk management.
• Ability to analyze, interpret, and apply government regulations, guidelines, and requirements.
• Ability to identify problems and work to implement solutions.
• Ability to exercise good judgment regarding the interpretation of policies, development of procedures, and selection of appropriate courses of action.
• Self-starter with strong drive for results and strong sense of ownership, but also willing to take direction.
• Superior communication and interpersonal skills.
• Ability to work in a team environment and assist others, as needed.

Qualifications:

• JD degree from an accredited law school and valid license in New Jersey (or eligibility for limited in-house license) and a minimum 4 years related legal experience representing life sciences companies.
• In-house, public company experience preferred.

Skills:

• Demonstrated collaborative approach with cross-functional partners
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.