Moderna Therapeutics Inc.
Senior Manager, Clinical Compliance
Moderna Therapeutics Inc., Cambridge, Massachusetts, us, 02140
The
Role:The Senior Manager, Clinical Compliance will provide support and guidance to clinical trial teams on Clinical Compliance requirements and activities. The candidate will work to support trial teams across different stages of development and multiple therapeutic areas. The successful candidate will be skilled at both understanding and applying internal procedures and policies as well as local and global regulations and processes to trials as the studies advance through development. The position requires a collaborative partnership with cross-functional team members across the organization.Here’s What You’ll Do:Collaborate with cross-functional clinical trial teams to ensure all trials are conducted in compliance with internal policies and procedures, global and local regulations, and ICH/GCP.Identify compliance risks, communicate risks, facilitate appropriate decision making with impacted functions, and escalate to management.Collaborate with cross-functional team members to answer compliance questions or direct compliance issues to appropriate subject matter experts.Keep abreast of regulatory developments across industry as well as evolving compliance best practices.Ensure that compliance issues associated with clinical audits or inspections are properly evaluated and adequately addressed in collaboration with study teams and R&D Quality.Support study teams with reporting of quality events, investigation of issues, root cause analysis, and CAPA plans.Assist in developing and monitoring key performance indicators (KPIs) for the compliance function to measure success and identify areas for improvement.Assist in driving continuous improvement initiatives within the clinical compliance function, utilizing new technologies and best practices.Here’s What You’ll Bring to the Table:BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).Knowledge and understanding of ICH GCP and other applicable regulations/guidelines.Excellent written and verbal communication skills.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
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Role:The Senior Manager, Clinical Compliance will provide support and guidance to clinical trial teams on Clinical Compliance requirements and activities. The candidate will work to support trial teams across different stages of development and multiple therapeutic areas. The successful candidate will be skilled at both understanding and applying internal procedures and policies as well as local and global regulations and processes to trials as the studies advance through development. The position requires a collaborative partnership with cross-functional team members across the organization.Here’s What You’ll Do:Collaborate with cross-functional clinical trial teams to ensure all trials are conducted in compliance with internal policies and procedures, global and local regulations, and ICH/GCP.Identify compliance risks, communicate risks, facilitate appropriate decision making with impacted functions, and escalate to management.Collaborate with cross-functional team members to answer compliance questions or direct compliance issues to appropriate subject matter experts.Keep abreast of regulatory developments across industry as well as evolving compliance best practices.Ensure that compliance issues associated with clinical audits or inspections are properly evaluated and adequately addressed in collaboration with study teams and R&D Quality.Support study teams with reporting of quality events, investigation of issues, root cause analysis, and CAPA plans.Assist in developing and monitoring key performance indicators (KPIs) for the compliance function to measure success and identify areas for improvement.Assist in driving continuous improvement initiatives within the clinical compliance function, utilizing new technologies and best practices.Here’s What You’ll Bring to the Table:BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).Knowledge and understanding of ICH GCP and other applicable regulations/guidelines.Excellent written and verbal communication skills.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
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