Senior Compliance Executive - Fixed Term Contract

Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value, Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence.

Due to a maternity leave, we are seeking a Senior Compliance Executive to coordinate all client compliance activities, including adverse events reporting, data privacy, and ethics considerations. This role supports the company by maintaining robust compliance systems, leading audits, and providing training and certification management. Additionally, the Senior Compliance Executive drives continuous improvement initiatives and develops specialized compliance areas to enhance value for research teams and clients. Coordinate all aspects of client compliance, including adverse events reporting, data privacy considerations, ethics considerations, and other client-specific requirements.

• Provide comprehensive compliance support to the company, including certification, training, and adherence to Master Service Agreements (MSAs).
• Develop and maintain systems to support and enhance internal compliance practices, ensuring they are efficient and robust.
• Lead and coordinate Pharmacovigilance (PV) audits, including information collection, scheduling, audit support, and oversight of findings and implementation of Corrective and Preventive Actions (CAPAs).
• Continuously seek opportunities to improve compliance systems through automation and technology to enhance efficiency while maintaining stringent compliance standards.
• Create and maintain company Standard Operating Procedures (SOPs) and client-specific guidelines, ensuring they are up to date and compliant with industry standards.
• Monitor and enforce BHBIA membership requirements, including adverse events and legal and ethical training certifications.
• Conduct internal audits and data protection reviews to ensure compliance with data protection laws and company policies.
• Develop areas of specialism within the compliance department to provide additional value to research teams and clients.
• Support the Project Management Team with ad hoc administrative requests and build effective relationships with internal and external stakeholders.

• In-depth knowledge of compliance regulations, including data privacy (GDPR), adverse events reporting, and industry-specific ethics considerations, with a minimum of 5 years of experience in compliance roles.
• Proven track record in managing client compliance, including certification, training, audits, and adherence to Master Service Agreements (MSAs).
• Strong organizational and project management skills, with experience in developing and maintaining compliance systems and documentation.
• Excellent communication and interpersonal skills, with the ability to liaise effectively with internal and external stakeholders and lead continuous improvement initiatives in compliance processes.