Description:
About the role:We are seeking a Director, Brand Counsel to serve as primary legal counsel supporting one of Insmed's marketed respiratory products. Brand Counsel will provide strategic and tactical legal advice for the brand and serve as legal reviewer of all promotional, non-promotional, and scientific materials and activities initiated in furtherance of the brand. This role will function as a key strategic partner with the brand team and will work closely with other members of the legal team and cross-functional partners, such as commercial, medical affairs, corporate communications, market access, patient advocacy, and compliance.
What You'll Do:
In this role, you will serve as the primary legal advisor and strategic partner to the brand team of a marketed respiratory product. You will provide strategic and tactical legal support in furtherance of the brand plan. You will report to the Executive Director, Corporate Counsel and partner closely with peers on the Legal team in support of the Respiratory Therapeutic Area.
You will have responsibility for:
- Serve as a trusted legal advisor and strategic partner to business leaders on the brand team.
- Provide proactive legal advice to business partners and drive legal strategy through the review of brand team initiatives in support of execution of brand plan for one of Insmed's marketed respiratory products in accordance with current FDA and FTC regulations, guidance, and enforcement activities with a focus on anti-kickback, false claims act, and advertising and promotional regulations, and counsel on risk mitigation strategies, as needed.
- Establish rapport and constructive working relationships with commercial, medical, and other cross-functional leaders and team members at all levels, encouraging proactive engagement with in-house legal counsel and operating as an active member of the legal and brand teams.
- Review promotional, non-promotional, and scientific materials and associated strategies and tactics for compliance with applicable guidance, laws and regulations and serve as primary legal member on the applicable review committees (e.g., Commercial Review Committee, Medical Review Committee).
- Review and provide legal advice on corporate communication and product communications and related internal and external activities and materials.
- Serve as contract review escalation point for related commercial, medical affairs, corporate communications contracts ensuring alignment with company standards and compliance with applicable laws and industry standards.
- Identify, communicate, and provide updates to business partners and the legal team on risks associated with day-to-day operational business activities and on current federal and state legal, regulatory, and enforcement developments related to the life sciences industry, including training clients on applicable legal issues within your expertise.
- Monitor and provide updates to business partners and legal team on current federal and state legal and regulatory risks and enforcement activities related to the life sciences industry.
- Partner with the business to proactively apply legal and regulatory guidance to brand tactics and strategy by understanding business goals and developing and implementing solutions to assist in the achievement of successful outcomes consistent with business objectives.
- Coordinate legal matters handled by outside counsel
Who You Are:
You have a JD degree from an accredited law school and valid license in New Jersey (or eligibility for limited in-house license) and a minimum of 5+ years related in-house legal experience representing life sciences companies.
In-house, public company experience preferred.
Additionally you have:
- Experience in promotional and non-promotional review, regulatory matters, risk management and contract management.
- Experience in contract, business, FDA, FTC, and laws and regulations specific to the life science industry.
- Excellent professional judgment and discretion and high standard of professional and ethical conduct.
- 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 proactively identify problems, strategize across a broad range of business, operations, and risk-management issues, and implement effective 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.
- Ability to foster open communication, share subject matter expertise, and collaborate to reach a resolutions that meet organizational and business objectives and address identified legal, regulatory, and compliance risks.
Travel Requirements:
This role requires occasional domestic travel of 10-20%.
Where You'll Work
This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.