Amgen
Regulatory Labeling Manager
Amgen, Washington, District of Columbia, us, 20022
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Regulatory Labeling Manager
Join Amgen's Mission of Serving Patients Lets do this. Lets change the world. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre- & post-marketed products over the product's life cycle. In this vital role, you will author, enable internal governance reviews, and manage the development of the Target Product Label, Core Labeling documents, and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s). Principal responsibilities include:
Authors and maintains core company labeling documents (including Core Data Sheet, Core Patient Information Leaflet, and Core Instructions for Use) in support of global marketing applications and variations. Leads the cross-functional Labeling team as a Labeling Strategy subject matter expert for the creation and update of labeling - for alignment and communication of labeling text at product launch. Authors US labeling documents (including USPI, Medication Guide, PPI, IFU) for the initial Marketing Authorization Application and updates for new indications, efficacy data, product quality changes, and safety-related topics. Presents to cross-functional and executive level management to obtain endorsement, as appropriate, for the proposed core document and US labeling text. Leads cross-functional teams (Labeling Working Group) to align on the proposed core document and US labeling text. Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends across the organization. Provides consultation to internal and/or external experts on the creation of high-quality core labeling documents and manages the dossier annotations within the documents. Provides strategic labeling advice for major regions and works with cross-functional teams to ensure that the implementation of global regulatory labeling plans are aligned with global regulatory strategies. Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are addressed appropriately. Supports preparation of responses to labeling-related Health Authority queries. Incorporates feedback from HF studies into the cIFU (e.g., with incorporation of participants output during the formative/summative studies into the labeling) and associated combination product labeling. Supports the continuous improvement of initiatives across the End to End labeling process. Supports creation of target product labeling. Manages the review and approval of core DHCP letters. Regulatory Labeling core member/SME on product-specific Global Regulatory Teams (GRT). What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree Or Masters degree and 2 years of related experience Or Bachelors degree and 4 years of related experience Or Associates degree and 8 years of related experience Or High school diploma / GED and 10 years of related experience Preferred Qualifications: Demonstrated experience in authoring, developing, and updating Pharmaceutical or Biotechnology product prescribing information labeling. Degree in pharmaceuticals, life science, or medicine. Knowledge of prescribing information labeling development within various Therapeutic Areas. Knowledge of FDA, or EMA, or other international regulations for prescribing information labeling with understanding the impact of emerging trends and their implications for Amgen. Project Management experience, experience managing individual and group projects of moderate complexity. Strong collaboration, presentation, communication, interpersonal, and leadership skills. Experience working in a Veeva-based RIM Regulatory Management system. What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan. Stock-based long-term incentives. Award-winning time-off plans. Flexible work models, including remote and hybrid work arrangements, where possible. Apply now
for a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Join Amgen's Mission of Serving Patients Lets do this. Lets change the world. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre- & post-marketed products over the product's life cycle. In this vital role, you will author, enable internal governance reviews, and manage the development of the Target Product Label, Core Labeling documents, and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s). Principal responsibilities include:
Authors and maintains core company labeling documents (including Core Data Sheet, Core Patient Information Leaflet, and Core Instructions for Use) in support of global marketing applications and variations. Leads the cross-functional Labeling team as a Labeling Strategy subject matter expert for the creation and update of labeling - for alignment and communication of labeling text at product launch. Authors US labeling documents (including USPI, Medication Guide, PPI, IFU) for the initial Marketing Authorization Application and updates for new indications, efficacy data, product quality changes, and safety-related topics. Presents to cross-functional and executive level management to obtain endorsement, as appropriate, for the proposed core document and US labeling text. Leads cross-functional teams (Labeling Working Group) to align on the proposed core document and US labeling text. Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends across the organization. Provides consultation to internal and/or external experts on the creation of high-quality core labeling documents and manages the dossier annotations within the documents. Provides strategic labeling advice for major regions and works with cross-functional teams to ensure that the implementation of global regulatory labeling plans are aligned with global regulatory strategies. Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are addressed appropriately. Supports preparation of responses to labeling-related Health Authority queries. Incorporates feedback from HF studies into the cIFU (e.g., with incorporation of participants output during the formative/summative studies into the labeling) and associated combination product labeling. Supports the continuous improvement of initiatives across the End to End labeling process. Supports creation of target product labeling. Manages the review and approval of core DHCP letters. Regulatory Labeling core member/SME on product-specific Global Regulatory Teams (GRT). What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree Or Masters degree and 2 years of related experience Or Bachelors degree and 4 years of related experience Or Associates degree and 8 years of related experience Or High school diploma / GED and 10 years of related experience Preferred Qualifications: Demonstrated experience in authoring, developing, and updating Pharmaceutical or Biotechnology product prescribing information labeling. Degree in pharmaceuticals, life science, or medicine. Knowledge of prescribing information labeling development within various Therapeutic Areas. Knowledge of FDA, or EMA, or other international regulations for prescribing information labeling with understanding the impact of emerging trends and their implications for Amgen. Project Management experience, experience managing individual and group projects of moderate complexity. Strong collaboration, presentation, communication, interpersonal, and leadership skills. Experience working in a Veeva-based RIM Regulatory Management system. What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan. Stock-based long-term incentives. Award-winning time-off plans. Flexible work models, including remote and hybrid work arrangements, where possible. Apply now
for a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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