Director, Compliance Operations

  • 10 Finderne Ave, Bridgewater, NJ 08807, USA
  • Full-time

Company Description

Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

Job Description

SUMMARY: 

With the Executive Director, Corporate Compliance, Policies and Training, implement and manage compliance operations functionality for Insmed’s Global Compliance group and provide guidance to Insmed’s US and global (EU, Japan) operations. This role will be based at our Bridgewater, New Jersey headquarters location.

This position reports directly to the Executive Director, Corporate Compliance, Policies and Training

This is a non-supervisory position at this time and may change as the Global Compliance function grows

 

RESPONSIBILITIES:

  • Implement and manage day-to-to operations for the hiring of healthcare professionals including process development, software implementation, fair market value and lifecycle management 
  • Implement and manage US transparency program with scalability to global, including oversight of outsourced reporting vendor
  • Support policy and process development, updates and translations as assigned along with any training or communications
  • Partner with the US, EU and Japan businesses to provide operational guidance and support as needed
  • Provide guidance and support to US business
  • Identify continuous improvement activities to continue to enhance and grow the compliance function
  • Lead remediation efforts as needed, resulting from compliance monitoring and auditing  

Qualifications

 

  • Bachelor’s degree required; advance degree preferred.
  • Compliance certification is a plus
  • At least 10 years’ experience in corporate compliance for a pharmaceutical or biotech company
  • Knowledge of US and global compliance regulations, laws and standards
  • Experience working globally (EU, Japan)
  • Experience in engaging healthcare professionals processes
  • In depth knowledge of US transparency laws and reporting processes
  • Experience in developing and implement compliance processes and software (e.g. hiring healthcare professionals’ software, third party due diligence software)
  • Experience in continuous improvement for compliance programs
  • Must have excellent communication skills (verbal and written). 
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness. 
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Domestic and international travel may be required occasionally (5-10%)
  • Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies. 
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Information

Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.