Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 This role will support the UK affiliate managing the UK Healthcare Compliance Program and the Senior Director Compliance with operational tasks for the Compliance Program in the EMEA region.

Additional representative responsibilities will include, but not necessarily be limited to, the following: Provide local compliance support and expertise to the affiliate in the UK and manage the UK Healthcare Compliance Program, including but not limited to the following tasks:

• Provide guidance and expertise on local code requirements (ABPI Code) to the UK team
• Develop and deliver local trainings
• Perform local monitorings
• Support risk assessments
• Develop and implement local SOPs and processes as needed

Support the Senior Director Compliance with operational tasks of the Healthcare Compliance Program in the EMEA region as follows:Management of the HCP Engagement Tool

• Overall management of the HCP engagement tool
• Review and approve activities
• Review and approve FMV rates
• Serve as the regional point of contact for any questions around the System
• Ensure close outs are done timely and complete

Transparency

• Support the transparency reporting in the region
• Prepare transparency reports for Belgium and France and other countries as required
• Follow up with the business and ensure data integrity for correct data reporting

Training

• Deliver compliance trainings
• Support the development of new training material
• Maintain the EMEA training matrix

Monitorings

• Support the monitoring efforts in the EMEA region under the guidance of the Senior Director Compliance
• Select and review samples
• Conduct monitorings and complete monitoring checklists
• Prepare monitoring reports
• Conduct field rides and other live monitorings in the countries
• Pull through remediation plans from monitorings

Management of Third Party Representatives (TPRs)

• Under the guidance and direction of the Senior Director Compliance perform due diligence on third party representatives
• Manage the third party representative tool for TPRs in the region

SOP and Process Development

• Support the development and drafting of new SOPs and/or processes in the region
• Support the Implementation of such new SOPs/processes

Together with the Senior Director Compliance, actively support Global Compliance Program initiatives and projects where appropriate and ensure UK/EMEA voice is understood and incorporated.

• Support training and awareness efforts to ensure Insmed employees outside of the UK/EMEA understand the unique legal/regulatory/code requirements of the UK/EU countries.

Position requirements :

• University degree in Business, Finance or Law
• Minimum of 5-7 years of compliance experience in the healthcare (bio/pharma/med device) industry
• Excellent written and verbal communication skills
• Strong understanding of the UK ABPI code
• Demonstrates strong interpersonal skills and ability to build strong work relationships with colleagues across all departments and levels of the organization
• Ability to drive projects to completion, meeting internal and external timelines driven with a high degree of accuracy and manage multiple projects simultaneously
• Proven ability to collaborate and advice management and colleagues on compliance and ethics matters and develop practical business solutions to mitigate risks
• Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion
• Experience with transparency reporting
• Flexible and adaptable
• Problem solving skills

Up to 20% travel based on requirements.

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by 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.

Applications are accepted until the position is filled.