Coordinator, Compliance | BioNJ Talent Services

Coordinator, Compliance

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

Translating Science. Transforming Lives.

Our mission at PTC Therapeutics has always been to build an integrated biopharmaceutical company based on our expertise in RNA biology. We have focused on discovering and developing novel oral treatments for patients with serious and life-limiting disorders. By targeting the processes that modulate RNA biology and affect protein production, we bring an innovative approach to drug discovery. We are focused particularly on the development and commercialization of treatments for rare and neglected disorders.

Commitment to Patients.

We are committed to finding treatment options for patients living with life-threatening diseases. Our lead product candidate is ataluren for the treatment of patients with genetic disorders due to a nonsense mutation. Ataluren is in clinical development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). Ataluren has been approved under the trade name Translarna™ in the European Union for ambulatory patients with nmDMD who are 5 years and older.

Job Description:

In this newly created position, the Coordinator, Compliance is responsible for assisting with the implementation and oversight of the company’s compliance with all applicable laws, regulations, guidance and industry standards, including, but not limited to, applicable interactions with healthcare professionals, promotional activities, anti-kickback, privacy, fraud and abuse, anti-bribery and transparency laws.

The incumbent works cross-functionally with internal departments and external resources on compliance related issues.

The Coordinator, Compliance supports adherence to relevant regulatory requirements and company policies as appropriate.

Primary duties/responsibilities:

*Coordinator for the Policy Management Committee, the Fee for Service Committee and the Funding/Grant Committee.

*Oversees and coordinates these processes which includes, but is not limited to, receiving requests for committee review, communicating with requestor as needed, preparing documents for reviewers, scheduling meetings, preparing and distributing agendas and meeting minutes, communicating committee decisions, drafting letters of agreement as needed, managing requests and related documents in system of record.

*Facilitates checks for FDA Debarment List and Excluded Parties List System (EPLS) System to assist in the government contracting process.

*Facilitates specific aspects of contract administration including, but not limited to, tiering healthcare professionals for fair market value decisions, facilitating the routing and tracking of contracts and drafting contracts for Compliance vendors.

*Provides support to the transparency reporting team including, but not limited to, the identification of healthcare professional/organization vendors and reviewing and maintaining data capture templates to ensure completeness of required fields. Works with stakeholders to input any missing required data to help ensure PTC’s compliance with transparency reporting requirements.

*Assists with preparing documentation for audits, maintaining audit database in SharePoint and scheduling visits with field personnel or other audit teams.

*Performs other tasks and assignments as needed and specified by management.

Qualifications: 

Education/experience required

Bachelor’s degree in a relevant discipline and a minimum of 3 years of related experience in a pharmaceutical, biotechnology or related environment OR equivalent experience and/or education.

* Special knowledge or skills needed and/or licenses or certificates required.

Basic knowledge and understanding of compliance regulations and industry guidance.

Demonstrated ability to assist with the facilitation of compliance issues and processes and the ability to communicate effectively in a complex organization.

Experience supporting commercial and medical affairs operations function for a pharmaceutical, biotechnology or similar company(ies).

Proven ability to facilitate complex issues relating to corporate governance, ethics, and fraud and abuse issues.

Demonstrated ability to work collaboratively and with a start-up oriented approach to compliance.

Possess a high energy level and strong work ethic with a commitment to continuous improvement in a dynamic environment that strives to exceed expectations.

High commitment to customer service and a highly developed sense of corporate and business ethics.

Exceptional interpersonal skills and excellent oral and written communication.

Proficiency with Microsoft Office.

Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

*Special knowledge or skills and/or licenses or certificates preferred.

Healthcare Compliance Certifications

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other