Talent.com
Compliance Senior Manager, U.S. Rare Disease
Compliance Senior Manager, U.S. Rare DiseaseAmgen • Oakland, CA, US
Compliance Senior Manager, U.S. Rare Disease

Compliance Senior Manager, U.S. Rare Disease

Amgen • Oakland, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Compliance Senior Manager, U.S. Rare Disease

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives 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 lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let's do this! Let's change the world! The Senior Manager, Rare Disease Compliance, will serve as one of the compliance business partners for the Amgen Rare Disease Business Unit (RDBU), serving on a team that works closely with that organization's leadership to uphold the reputation of Amgen and drive ethical solutions for the patients it serves.

As a member of Amgen's Worldwide Compliance & Business Ethics organization, the Senior Manager, Rare Disease Compliance, will work with various cross-functional organizations including Law, Regulatory, and Privacy to appropriately advise the business on how best to maintain a strong culture of compliance, integrity, and ethics, and mitigate risk related to key strategic initiatives.

Reporting to the Senior Director of Rare Disease Compliance, this individual will leverage understanding and knowledge of the U.S. regulatory, enforcement, and compliance environment within the biopharmaceutical industry, with particular experience in interpreting :

  • FDA drug promotional requirements
  • U.S. privacy requirements
  • Government transparency reporting
  • Industry standards for compliance and ethics (PhRMA Code)

Responsibilities

  • Proactively support and anticipate RDBU compliance needs by embedding within assigned leadership teams and providing compliance guidance
  • Assist with development of multi-dimensional strategies tailored to the unique circumstances and needs of each RDBU business that incorporate learnings from monitoring, investigations, business engagement, and industry developments
  • Engage and work closely with RDBU leadership to develop and drive solutions that elevate ethical decision-making and honorably secure access for current and future patients.
  • Leverage knowledge of the rare disease landscape and regulatory environment to thoughtfully and openly advise the RDBU
  • Monitor industry-wide compliance and enforcement trends
  • Be prepared to travel to conferences, internal training, and / or meetings to support RDBU Compliance initiatives
  • What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Compliance professional we seek will meet these qualifications.

    Basic Qualifications :

    Doctorate degree and 2 years of experience in compliance or legal supporting bio-pharmaceutical business

    Or

    Master's degree and 4 years of experience in compliance or legal supporting bio-pharmaceutical business

    Or

    Bachelor's degree and 6 years of experience in compliance or legal supporting bio-pharmaceutical business

    Or

    Associate's degree and 10 years of experience in compliance or legal supporting bio-pharmaceutical business

    Or

    High school diploma / GED and 12 years of experience in compliance or legal supporting bio-pharmaceutical business

    Preferred Qualifications :

  • Proven skills in developing and implementing strategies and results in a complex and dynamic organization
  • Ability to prioritize work-related tasks and effectively communicate with leadership
  • Strong written, spoken, and interpersonal communication skills with attention to detail; polished, poised presenter
  • Ability to efficiently navigate an exciting and dynamic environment
  • Strong critical thinking, problem-solving and planning skills
  • Commitment to collaborating remotely with a diverse group of people and backgrounds
  • Entrepreneurial spirit, passion, and creativity
  • What you can expect of 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 and make a lasting impact with the Amgen team.

    In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

    Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

    Sponsorship for this role is not guaranteed.

    As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

    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.

    [job_alerts.create_a_job]

    Compliance Manager Us • Oakland, CA, US

    [internal_linking.related_jobs]
    Senior Manager, Incentive Compensation

    Senior Manager, Incentive Compensation

    Crusoe • San Francisco, CA, US
    [job_card.full_time]
    Crusoe's mission is to accelerate the abundance of energy and intelligence.We're crafting the engine that powers a world where people can create ambitiously with AI — without sacrificing scale, spe...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Director, SOX Compliance

    Director, SOX Compliance

    Omada Health • South San Francisco, CA, United States
    [job_card.full_time]
    Omada Health is on a mission to inspire and engage people in lifelong health, one step at a time.The Director of SOX Compliance will play a critical role in safeguarding Omada's financial integrity...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager - Compensation Consulting

    Senior Manager - Compensation Consulting

    Rsm Us Llp. • San Francisco, California, United States
    [job_card.full_time]
    Senior Manager - Compensation Consulting page is loaded## Senior Manager - Compensation Consultinglocations : .Posted 12 Days Agojob requisition id : . JR113211We are the leading provider of professiona...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, US Ethics & Compliance Advisor, HIV Treatment

    Senior Manager, US Ethics & Compliance Advisor, HIV Treatment

    Gilead Sciences • Foster, California, USA
    [job_card.full_time]
    At Gilead were creating a healthier world for all people.For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, AQRM

    Senior Manager, AQRM

    RSM • Oakland, CA, US
    [job_card.full_time]
    Audit Quality & Risk Management Manager.We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Clinical Development

    Senior Director, Clinical Development

    Annexon Bioscience • San Francisco, CA, United States
    [job_card.full_time]
    At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammat...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, U.S. Market Access Strategy - HIV

    Senior Director, U.S. Market Access Strategy - HIV

    Gilead Sciences, Inc. • Foster City, CA, United States
    [job_card.full_time] +1
    Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Market Access Strategy, HIV, you will be reporting ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Manager, Compensation Consulting

    Senior Manager, Compensation Consulting

    RSM US LLP • San Francisco, CA, US
    [job_card.full_time]
    We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their ful...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Compliance Manager

    Senior Compliance Manager

    Roblox • San Mateo, CA, US
    [job_card.full_time]
    For roles that are based at our headquarters in San Mateo, CA : The starting base pay for this position is as shown below. The actual base pay is dependent upon a variety of job-related factors such ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, AR & Reserves Compliance (GAAP / SEC)

    Senior Manager, AR & Reserves Compliance (GAAP / SEC)

    Axon Enterprise • San Francisco, CA, US
    [job_card.full_time]
    A technology company is seeking a Senior Manager, Accounting Compliance for its San Francisco office.This role requires a CPA with deep technical accounting knowledge, overseeing accounts receivabl...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Medical Director

    Senior Medical Director

    San Francisco Health Plan • San Francisco, CA, United States
    [job_card.full_time]
    Reporting to the Chief Medical Officer (CMO), the Senior Medical Director provides strategic clinical leadership and oversight for SFHP's Medical Directors and Quality Review teams.You will be the ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Manager, Applied Science - Payment Risk ML

    Senior Manager, Applied Science - Payment Risk ML

    Amazon • San Francisco, CA, United States
    [job_card.full_time]
    A leading technology company is seeking a Sr.Manager of Applied Science to lead a team in developing innovative machine learning solutions for eCommerce fraud prevention. This role requires strong l...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Senior Director, Clinical Operations Compliance Management (Biotechnology / Oncology)

    Senior Director, Clinical Operations Compliance Management (Biotechnology / Oncology)

    Exelixis • Alameda, CA, United States
    [job_card.full_time]
    The Senior Director, Clinical Operations Compliance Management (COCM) is responsible for ensuring that clinical research activities are conducted by clinical staff in accordance with ICH GCP, relev...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, Strategic Fulfillment Initiatives

    Senior Manager, Strategic Fulfillment Initiatives

    Flexport • San Francisco, CA, United States
    [job_card.full_time]
    A global logistics company is seeking a Sr.Manager, Strategic Initiatives in San Francisco.The successful candidate will design and build processes for the fulfillment network while leveraging data...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Risk Manager

    Senior Risk Manager

    Otsuka America, Inc. • San Francisco, CA, United States
    [job_card.full_time]
    This range is provided by Otsuka America, Inc.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Direct message the job poster from Otsuka America,...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Compliance Insights Program Lead

    Compliance Insights Program Lead

    Block • San Francisco, CA, United States
    [job_card.full_time]
    As the Compliance Insights Program Manager, you will design a new program and stand up a team focused on measuring bad activity prevalence on our platforms. You will drive strategy, training, and wi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Compliance Lead

    Senior Compliance Lead

    Boeing • Berkeley, California, USA
    [job_card.full_time] +2
    The Boeing Company is currently seeking a.Berkeley MO; North Charleston SC; Dallas TX; Everett WA; Huntsville AL; Mesa AZ. San Antonio TX; Seattle WA; Tukwila WA El Segundo CA; Long Beach CA; Miami...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Leader, Enterprise Risk & Compliance Strategy

    Senior Leader, Enterprise Risk & Compliance Strategy

    Visa • Foster City, CA, United States
    [job_card.full_time]
    A global payments technology company is seeking a Senior Manager for Enterprise Risk Management.This role involves leading the development of the ERM framework, managing risk assessments, and prepa...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]