Current Job Openings
Associate Director, Legal - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for an Associate Director, Legal with a biotech company in Lenoir, NC who possesses:
- Juris Doctor (JD) degree from an accredited law school
- Must possess an active bar membership in good standing
- 5+ years of legal experience in the pharmaceutical, biotechnology, or healthcare industry
- Expertise in healthcare compliance laws including FDCA, AKS, FCA, HHS-OIG guidance, FDA regulations, and the PhRMA code
- Proficient providing contracting and commercial law support
Email resumes to aencarnacion@simplybiotech.com or call 858.427.3668.
FULL DESCRIPTION: The Associate Director, Legal will serve as a key in-house attorney, providing strategic legal counsel across the organization with a primary focus on contract management, sponsorship and grants review, and promotional material compliance. This role requires deep expertise in pharmaceutical and biotech industry regulations and the ability to partner cross-functionally to support business objectives while ensuring compliance with applicable healthcare laws and company policies.
The selected candidate will be responsible for:
Contracting & Commercial Support
- Lead the day-to-day management of the company's contracting function, including drafting, reviewing, negotiating, and interpreting a broad range of contracts of varying complexity.
- Serve as a primary legal advisor to internal business functions, including Commercial, Information Technology, Marketing, Medical Affairs, and other departments, to provide full-service contracting support.
- Evaluate and negotiate agreements typical to the pharmaceutical and biotech industry, including confidentiality agreements, consulting agreements, master service agreements, licensing agreements, distribution agreements, and supply agreements.
- Provide practical legal advice on contractual risks, ensuring alignment with business objectives and regulatory requirements.
- Partner with stakeholders to enhance and streamline the contracting process, ensuring efficiency and consistency across agreements.
Sponsorships & Grants Review
- Oversee and manage the company's Sponsorships and Grants review process, ensuring compliance with internal policies and external regulatory requirements.
- Provide guidance on appropriate funding requests, sponsorship agreements, and grant allocations in accordance with healthcare compliance laws and industry standards.
Healthcare Compliance & Promotional Review
- Advise internal teams on commercial, brand, and medical initiatives, ensuring compliance with key healthcare laws, regulations, and guidance.
- Serve as a legal reviewer for promotional, educational, and training materials related to the company's products, assessing and mitigating potential healthcare compliance risks.
- Provide legal counsel on compliance with the Federal Food, Drug & Cosmetic Act, the Anti-Kickback Statute (AKS), the False Claims Act (FCA), HHS-OIG guidance, FDA regulations, and the PhRMA Code on Interactions with Healthcare Professionals.
Risk Management & Business Partnership
- Quickly and effectively identify complex legal and compliance issues, providing strategic guidance that balances legal risk with business goals.
- Collaborate with the managing attorney and cross-functional teams to develop and implement legal policies, procedures, and training programs.
- Monitor and interpret evolving laws, regulations, and industry trends that impact the pharmaceutical/biotech sector, advising the company accordingly.
- Develop and maintain strong working relationships with internal stakeholders as a trusted business partner.
The selected candidate will also possess:
- Minimum of 5 years legal experience in the pharmaceutical, biotechnology, or healthcare industry.
- Juris Doctor (JD) degree from an accredited law school.
- Active bar membership in good standing. with the license to practice law.
- Strong background in contract negotiation, drafting, and review within a regulated industry.
- Expertise in healthcare compliance laws, including the FDCA, AKS, FCA, HHS-OIG guidance, FDA regulations, and the PhRMA Code.
- Experience providing legal review of promotional and marketing materials in a pharmaceutical/biotech setting.
- Ability to manage multiple priorities in a fast-paced environment while delivering practical, business-oriented legal solutions.
- Excellent interpersonal and communication skills, with the ability to collaborate effectively across functions.
Salary Range: $170k-190k/yr
For immediate and confidential consideration, please email your resume to aencarnacion@simplybiotech.com or call 858.427.3668. More information can be found at www.simplybiotech.com
For immediate and confidential consideration, please email your resume to aencarnacion@simplybiotech.com or call 858.427.3668. More information can be found at www.simplybiotech.com