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 RoleThe 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 DoProvide 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.Experience/KnowledgeWho 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.Skills/Capabilities/CompetenciesExcellent communication skills with the ability to effectively present ideas and influence others that achieve desired results (verbal and written / Japanese and English)Highly organized with a strong attention to priority, detail, clarity, accuracy, and concisenessDemonstrated experience in improving, developing, and implementing new processes.Ability to work collaboratively and effectively across functions as a team player and to build and foster strong relationships across the organization.Ability to interact successfully in a dynamic and culturally diverse workplace.Highest level of integrity to protect confidential informationHighly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams)Qualification/CertificateBachelor’s degree required; Business or Law degree is preferred.At least 5 years’ experience in ethics, corporate compliance and/or legal for a pharmaceutical, biotech or medical devices company with significant experience in day-to-day operations of HCC programs.OthersMust successfully exhibit Insmed’s five values such as “Collaboration, Accountability, Passion, Respect and Integrity.”Must demonstrate high level of personal and professional maturity.Non-smoker.Travel up to 15% (domestic and international), some of which will be overnight in nature.Life at Insmedインスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。社員一人一人の充実した働き方を実現するためのサポート： ワークライフバランスの実現フレキシブルな勤務時間や充実した休暇制度 魅力的な報酬制度退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会 キャリア開発支援社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修 先進的な学習支援AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント グローバルの表彰制度や従業員リソースグループ活動 ハイブリッドワーク環境の整備場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制Current Insmed Employees: Please apply via the Jobs Hub in Workday.Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, 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.Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.Applications are accepted for 5 calendar days from the date posted or until the position is filled.