Senior Manager, Compliance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: The primary purpose of this role is to provide corporate and healthcare compliance (“HCC”) support for Insmed in Japan. The role is responsible for providing business guidance, implementing standards and regional standard operating procedures, and delivering training in relation to applicable laws, regulations, guidelines, and codes associated with HCC, including but not limited to Pharmaceuticals and Medical Devises Act, MHLW Guidelines for Promotional Information Provision Activities, and Fair Competition Codes. This role will be based at our Tokyo location. This is a non-supervisory position. What You'll Do: Provide business guidance and consultation across Insmed’s Japan business, including interactions with healthcare professionals, government officials and third-party intermediaries, and provision of promotional information of products. In collaboration with the Head of Compliance, Japan and Japan Compliance team, deploy, execute and help maintain internal controls, risk assessments and risk-based compliance monitoring plans to ensure that Insmed colleagues and business partners follow applicable laws, regulations, guidelines and/or codes, and company policies and procedures in addition to partnering on development and execution of training. Support the Head of Compliance, Japan, in implementing and operationalizing Insmed’s policies and procedures, working closely and in collaboration with the business functions. Maintain a working knowledge of developments in applicable laws, regulations, guidelines, and/or codes, as well as initiatives and enforcement trends on a local, regional and global scale, and actively share such information across relevant functions. Manage day-to-day operations of the local HCC function. Participate in internal HCC related committees. Develop effective communication and compliance training for the business on HCC initiatives and deliver them to ensure understanding of employee responsibilities, ethics, and compliance as well as related policies and procedures. Participate in HCC related meetings held by local industry associations and healthcare authorities, as appropriate. Respond to requests for information by the Global Compliance audit and inspection team and implement corrective actions and preventative actions (CAPAs) resulting from HCC Audits. Lead, or collaborate on, as appropriate, the development, management and implementation of various technology solutions, compliance related systems or processes in support of business needs. Manage additional projects as identified, in support of key HCC initiatives. Conduct or collaborate on investigations into allegations of misconducts, as required. Work collaboratively with Global Compliance colleagues and contribute to shaping Insmed’s Global Compliance Program by actively participating in Global Compliance initiatives when appropriate and applicable. Participate in Global Compliance team meetings, including in-person team meetings and monthly team meetings, as required. Who You Are: Detailed knowledge of applicable laws, regulations, guidelines, codes, and standards. Experience in continuous improvement for compliance programs. Experience in conducting/being involved into internal compliance investigations. Excellent communication skills with the ability to effec ... (truncated, view full listing at source)