*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Conducts periodic internal reviews, monitoring and auditing in addition to those conducted by Acorda departments to ensure that compliance policies and procedures are followed, including, but not limited to, live field monitoring of company events and activities of field employees.
- Assists in the development, design and implementation of compliance training throughout the company and keeps the company abreast of updates in applicable laws and regulations.
- Works with Executive Director of Compliance, legal, and HR in conducting or directing the internal investigation of compliance issues to include investigation, follow-up, and resolution activities and solutions.
- Assesses product, compliance, and/or operational risks and helps develop risk management strategies.
- Assists in the administration of the Corporate Governance Hotline.
- Conduct internal needs assessments to identify compliance support needed on a continuing basis
- Drafts policies and standard operating procedures on behalf of Compliance and assists other departments with the review and drafting of policies and standard operating procedures
Education and/or Experience:
- JD required and admission to and in good standing with the bar in at least one state or the District of Columbia required.
- Minimum of eight to ten years progressive overall legal experience.
- Minimum of five years compliance experience required.
- Previous in-house legal experience with a biotech or pharmaceutical company required.
Supervisory Responsibilities: None
- Must have extensive knowledge and understanding of laws and regulations applicable to the biopharmaceutical industry, including but not limited to OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Professionals, and the Foreign Corrupt Practices Act.
- Must be proficient in MS Office Suite.
Certificates, Licenses, Registrations: None Required
Other Skills and Abilities:
- Excellent writing, communication, presentation, skills.
- Strong leadership and organizational skills.
- Demonstrated leadership, communication and analytical skills.
- Excellent project management and teamwork skills.
- Proven ability to work on multiple projects in a fast paced environment.
- Excellent time management skills and a proven ability to work on multiple projects at any given time.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires minimal travel; average travel for this position is 10 – 20% with some variation based upon the demands of the business imperatives.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.