Director, Compliance

Apellis Pharmaceuticals, Inc. Waltham , MA 02154

Posted 6 months ago

Position Summary:

Reporting to the General Counsel, the Director, Compliance will be responsible for the development, implementation, oversight, and continuous improvement of Apellis' healthcare compliance program. The successful incumbent will set and communicate standards in policies and procedures, implement SOPs, organize committees for compliance functions, create and implement training and communications, audit, monitor and investigate assurance and compliance activities and maintain constant communication with the executive team on all compliance matters.

Responsibilities:

  • Draft and implement appropriate policies, in collaboration with Legal and other Ethics & Compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in multiple countries (excluding cGMP, cGCP and other GXP guidelines)

  • Design and execute routine and risk-based monitoring and auditing of relevant business activities and related policies and procedures; assist in and oversee the implementation of corrective action plans as necessary; and generate and deliver reports to leadership on monitoring, auditing and risk assessment

  • Assist in implementation and execution of risk based third party due diligence

  • Conduct or assist in investigations into reported compliance concerns or any allegations of misconduct, as required

  • Participate in various Legal & Compliance Department projects and initiative

Education, Registration & Certification:

  • Bachelor's Degree Required
  • JD Preferred

Experience:

  • 7-10 years of ethics, compliance or a mix of compliance and legal experience in an organization subject to global biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations, preferably in rare diseases

Skills, Knowledge & Abilities:

  • Knowledge of laws and regulations applicable to global pharmaceutical companies e.g. the Foreign Corrupt Practices Act, US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals

  • Solid working knowledge of other laws, regulations, and industry standards

  • Consummate team player with excellent judgment and interpersonal skills

  • Ability to communicate effectively with all levels of management and employees

  • Demonstrable experience taking ownership of issues and providing timely, actionable guidance

  • Strong oral and written communication and influencing skills and the ability to proactively and pragmatically collaborate cross-functionally

  • Strong analytical, organizational, and problem-solving skills

  • Excellent project management skills with the ability to manage multiple priorities simultaneously

  • Self-starter with demonstrated leadership skills and ability to meet goals given limited supervision; able to exercise sound judgment in balancing risks in ambiguous and complex situations and escalating matters appropriately

  • Demonstrated superior ability to identify areas for improvement in controls, systems, and processes and implement effective solutions

  • Ability to work with large amounts of data to analyze information while still seeing the "big picture"

  • Confidence and professionalism to handle difficult conversations and discretion on sensitive matters

  • Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude

  • Ability to travel approximately 25% of time

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage bio-pharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.


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Director, Compliance

Apellis Pharmaceuticals, Inc.