Dir, Compliance | BioNJ Talent Services

Dir, Compliance

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

PTC is biopharmaceutical company focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC’s internally-discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology and infectious diseases. For more information on the company, please visit our website www.ptcbio.com. ​

Job Description:

The Director, Compliance is responsible for assisting with the pragmatic implementation of the PTC compliance program and for helping to ensuring PTC’s compliance with applicable laws, regulations guidance and industry standards. This includes, but may not be limited to, applicable anti-corruption, anti-kickback, privacy, fraud and abuse, anti-bribery and transparency laws.

He/She proactively identifies compliance risks, engages appropriate key stakeholders around risk awareness and mitigation and provides support to ensure actions/outcomes are aligned at the global, regional and, as applicable, country level. This involves close collaboration with the Legal department and internal business teams to ensure an understanding of their needs and to foster a trusted partnership around compliance-related matters.

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

The Director, Compliance helps to ensure adherence to relevant compliance and regulatory requirements and company policies as appropriate.

Job Description:

Primary duties/responsibilities:
Assists in developing, implementing, managing and enforcing the company’s global compliance program.
Provides advice and counsel daily with respect to compliance matters.
Leads the creation and maintenance of all compliance policies and policy manuals including global, regional and local policies.
Leads and manages the development and implementation of the global annual training plan including design and delivery of training.
Assists with auditing, monitoring and transparency as needed.
Represents the Compliance function on committees as assigned.
Assists in building and driving a culture of compliance throughout the organization.
Offers strategic advice with respect to the roll out of the compliance program within a specified region or country.
Performs other tasks and assignments as needed and specified by management.

Qualifications: 

Minimum level of education and years of relevant work experience:
Bachelor’s Degree in a relevant discipline and a minimum of 8 years of progressively responsible and relevant compliance experience in a pharmaceutical, biotechnology or related environment.

Special knowledge or skills needed and/or licenses or certificates required:
Demonstrated knowledge and understanding of compliance regulations and industry guidance including, but not limited to, anti-corruption, anti-bribery laws; data privacy laws; transparency laws; industry codes and guidance; rules and regulations regarding the promotion of pharmaceuticals; and regulations and standards within the assigned region.
Demonstrated knowledge of international healthcare compliance rules and regulations.
Demonstrated management of compliance issues and processes.
Ability to communicate effectively in a complex organization.
Experience supporting commercial and medical affairs operations functions.
Proven ability to manage complex issues relating to corporate governance, ethics, and fraud and abuse issues.
Ability to work with large amounts of data to analyze information while still seeing the "big picture".
Demonstrated ability to apply a collaborative, practical, start-up-oriented approach to compliance with a deep understanding of the ethics and compliance issues unique to the pharmaceutical industry.
Demonstrated ability to combine a high level of energy and a strong work ethic with a commitment to continuous improvement in a dynamic environment that strives to exceed expectations.
Demonstrated ability to balance a strong commitment to customer service with a highly developed sense of corporate and business ethics.
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Exceptional interpersonal skills and excellent oral and written communication.
Proven ability to work independently and collaboratively, as required, in a fast-paced, matrixed and team environment characterized by a strong team spirit.
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.
Special knowledge or skills and/or licenses or certificates preferred:
Healthcare Compliance Certifications
Travel requirements:
Up to 10 %

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