Legal & Contracting Specialist (Pharmaceutical)

Avadel Pharmaceuticals PLC; United States; Remote; USD 50,000 - 80,000; Full time

Job summary

Avadel Pharmaceuticals PLC is seeking a Legal & Contracting Specialist to oversee contract lifecycle management and support operations in a pharmaceutical setting. This fully remote role requires strong expertise in contracting and compliance, with a focus on collaboration across various business units. The ideal candidate will have substantial experience in legal support within the pharmaceutical industry and a proven track record of managing contracts effectively.

Qualifications

• Minimum 8 years of legal and/or contracting professional experience.
• 5 years recent experience in the pharmaceutical industry focusing on contracting.
• Strong knowledge of laws and regulations applicable to the pharmaceutical industry.

Responsibilities

• Draft, review, and negotiate a variety of contracts including Confidentiality and Master Service Agreements.
• Collaborate with attorneys and departments to ensure timely contract execution.
• Enhance contract workflows and compliance through process improvements.

Skills

Strong written and verbal communication

Project management

Legal and regulatory knowledge

Attention to detail

Education

Paralegal certification (preferred)

Tools

Contract management systems

Legal technology tools

Job description

Legal & Contracting Specialist (Pharmaceutical)

Legal & Contracting Specialist (Pharmaceutical)

About Avadel Pharmaceuticals Plc

About Avadel Pharmaceuticals Plc

Who We Are: Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Oxybate therapy is currently the standard of care for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients living with narcolepsy. However, other approved oxybate products are immediate release formulations requiring two nightly doses - one dose at bedtime and the second dose 2.5-4 hours later, in the middle of the night. LUMRYZ TM (sodium oxybate) extended release for oral suspension, applies our proprietary drug delivery technology to allow for a single bedtime dose, eliminating the need to have a forced awakening during the middle of the night and giving patients the chance for an uninterrupted night’s sleep. An extended-release medication sounds like a simple innovation, but it has been lacking for more than 20 years prior to our May 1, 2023 approval, and we believe this can be transformative for people with narcolepsy. For more information, please visit www.avadel.com or check out narcolespydisrupts.com.

What We Do: FDA-approved LUMRYZ (sodium oxybate) is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA found LUMRYZ to be clinically superior to currently marketed twice-nightly oxybate products and granted LUMRYZ seven years of Orphan Drug Exclusivity for adults on May 1, 2023, and again for pediatric patients 7 years and older on October 16, 2024. In both instances, FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal awakening to take a second dose.

How We Work: At Avadel, patients are the reason we exist, and our employees are our greatest competitive advantage – our “secret sauce.” The way we work is as important as the results we achieve. Our employees work together as ONE team and live our Values, which is what makes working at Avadel so special and why we will win for patients. Our ONE Team approach fosters a culture based on being relentless for patients, having confidence with humility , being courageous , taking insights to impact, and togetherness . In everything we do, we live the Avadel Values so we can be our best for our patients, our community and each other.

We need individuals who will dive in, roll up their sleeves, and join us to continue the LUMRYZ launch and our mission to serve the narcolepsy community.

Position Summary

The Avadel Legal Team is seeking an experienced pharmaceutical Legal & Contracting Specialist, with strong expertise supporting a broad range of contracting across a pharmaceutical organization, including but not limited to commercial as well as research and development functions. This individual is expected to oversee a high volume of contracts and to collaborate within the Legal team and a variety of departments to ensure the contracts are completed in a timely manner and in compliance with our policies. This position requires experience with contract lifecycle management systems and best practices to manage contract workflows, approvals, and document storage. This role is a great fit for an experienced paralegal, but that certification is not required - depth and relevance of contracting experience will be prioritized. This is a fully remote role.

In addition, this role will support operational compliance-related matters, as needed, which could include assistance with (for example) aggregate spend reporting, training and policy tracking, auditing/monitoring, screenings and/or state registrations. The successful candidate must have the flexibility to take on special projects and/or additional responsibilities as needed.

Essential Functions

These may include but are not limited to:

• Take ownership and draft, review and negotiate various types of agreements in support of multiple business units and the Company’s pharmaceutical products, including but not limited to, Confidentiality Agreements, Master Service Agreements, Statements of Work, Consulting Agreements, Amendments, Commercial Supply Agreements, General Services Agreements, Pharmacovigilance Agreements, Investigator Initiated Study Agreements, Clinical Trial Agreements, etc.
• Work closely with attorneys, the Finance department and business personnel to support timely initiation, negotiation, review, execution, and administration of contracts.
• Ensure contract consistency with current guidance and/or policy; review, draft, and document suggested language changes, and oversee resolution of all proposed changes to agreements.
• Identify and resolve routine and moderately complex legal matters within area of responsibility with minimal supervision.
• Develop knowledge of Avadel business and quickly identify issues for appropriate escalation.
• Lead and contribute to special projects related to contract management and process improvements, including the development of new policies, templates, playbooks, standard operating procedures (SOPs), training materials, and other support documents to enhance efficiency and compliance.
• Identify and implement process improvements to streamline contract workflows, enhance automation within the contract lifecycle management system, and improve collaboration between Legal and cross-functional teams.
• Provide operational support to compliance on matters including tracking of policies and training, screenings and registrations required by state law and other compliance related initiatives.
• Perform special tasks and assignments as required by management.
  
  

Experience And Qualifications

• Minimum of 8 years legal and/or contracting professional experience.
• Minimum of 5 years of recent experience in the pharmaceutical industry providing direct legal support with a strong focus on contracting for Research & Development and Commercial functions.
• Paralegal certification is preferred.
  
  

Skills & Experience

• Strong written and verbal communication skills, with the ability to manage projects, coordinate multiple priorities, and engage effectively across teams.
• Must have working knowledge of laws, regulations and industry guidelines applicable to the pharmaceutical industry, including without limitation, Federal Food, Drug and Cosmetic Act and related regulations, Federal Anti-kickback Statute, False Claims Act, OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the PhRMA Code on Interactions with Healthcare Professionals.
• Proficient in the use of contract management systems, as well as legal technology tools, spreadsheets, databases and word-processing applications.
• Ability to establish credibility quickly, build strong relationships across departments and with external stakeholders, and serve as a trusted legal resource.
• High attention to detail, accuracy, and the ability to maintain consistency in contract terms, processes, and compliance requirements.
• Amenable to on-the-job training in operational compliance matters.
  
  

Avadel is committed to facilitating an open, honest, inclusive, transparent, and productive work environment where we work together as ONE team and ONE culture to be our best for patients, customers, and each other. Avadel is committed to equal employment opportunities and non-discrimination in employment. We believe that all employees and applicants should be treated with courtesy, dignity, and respect. Avadel does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, marital status, ancestry, gender, gender identity, pregnancy, status as a covered veteran, or any other characteristic protected by federal, state, and/or local law. It is our intent to comply with federal, state, and local laws, regulations, and guidelines in our employment practices and in our service to our clients. This policy applies to all terms and conditions of employment including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

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