Senior Compliance Director & Legal Counsel

Description

Summary:

We are seeking a motivated and enthusiastic individual to join our dynamic and supportive team. In this role, you will have the opportunity to learn a breadth of skills while driving impactful programs that contribute to our organizational goals. You will collaborate with various departments and stakeholders to ensure the successful execution of projects and initiatives.

The Senior Compliance Director and Legal Counsel reports to the EVP, General Counsel, Secretary & Compliance Officer, and is responsible for management of the compliance program and providing legal support to all TerSera business functions for TerSera Therapeutics LLC (TerSera).  

Essential Duties and Responsibilities:

This section contains a list of the major responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

• Provide pharmaceutical law and healthcare compliance-related legal support for TerSera.
• Exercises independent expertise and judgment to mitigate risk.
• Legal reviewer for TerSera’s medical material, promotional review system and oversees timely submissions of promotional materials to FDA OPDP.
• Compliance program responsibilities, including employee training, employee monitoring and investigations, sales compliance field rides, HCP engagement compliance, aggregate spend tracking and reporting, drug takeback program, general state compliance reporting, including state drug price transparency, PhRMA Code analysis, Innovative Medicines Canada Code analysis, and general compliance oversight.
• Oversees Open Payments annual filings.
• Contribute to the legal department’s support of the business.
• Draft, review, and negotiate company agreements.
• Manage storage process for TerSera agreements and legal documents.
• Participate in business development transactions as needed.
• Manage outside counsel.
• Manage company licenses and business registrations with various states.
• Routine duties are performed with minimal supervision; standard practices or procedures allow employee to proceed alone at routine work; has strong communication of ongoing work; and risk escalation..
• Maintains a positive and professional demeanor toward all customers and coworkers. 
• Adheres to all policies and procedures of TerSera Therapeutics.
• Performs other duties as assigned. 
• Provide leadership to others through example and sharing of knowledge/skill

Non-Essential Functions:

• Maintains a positive and professional demeanor toward all customers and coworkers. 
• Adheres to all policies and procedures of TerSera 
• Performs other duties as assigned. 
• Provide leadership to others through example and sharing of knowledge/skill.

Requirements

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Knowledge of healthcare laws, pharmaceutical compliance laws and regulations, and OPDP regulatory standards related to promotional materials
• Excellent organizational skills, strong oral and written communication skills, and will be able to work in a high paced, timeline driven corporate office setting

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.

• Must have a Juris Doctor (JD) degree from an accredited law school
• Minimum of three years experience in a healthcare or pharmaceutical legal department or law firm