R&D Operations Senior Manager (Open to Remote)

Amgen

Thousand Oaks California

United States

Customer Service / Call Center
(No Timezone Provided)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

R&D Operations Senior Manage r (Open to Remote)

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work toward multiple goals that will enable outstanding medicines to move through the commercialization pipeline bringing therapies to patients.

Amgen is seeking a  R&D Operations Senior Manager  to join the Research and Development Strategy and Operations organization. In this role, you will lead a team that is responsible for managing nonclinical activities and deliverables for regulatory submission. You will also be responsible for Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) inspection readiness for regulated business units, including internal bioanalytical laboratories. In addition, you will oversee the GLP Archive (storage of GPL materials) and fulfill the duties of the eData Archivist. You will be the technical subject matter expert and serve as a key resource for issue resolution, questions and best practices. To achieve this, the manager is a creative problem solver who can deliver meaningful value-driven results that keenly drive productivity and efficiency.

You will be part of the larger corporate mission of bringing medicines to patients with unmet medical needs every day. Our scale is global and supports our nonclinical and clinical trials around the world. Please join an outstanding team that delivers for our partners!

Key responsibilities include, but are not limited to:

  • Collaborate closely with R&D Compliance and the regulated (GLP/GCP) business areas to ensure a compliance-focused environment in preparation for regulatory inspections and audits
  • Facilitate inspection management activities by supporting business areas during inspections and audits
  • Accountable for maintenance of GLP Archive in accordance with GLP regulations and retention strategy
  • Manage a team of professionals responsible for end-to-end project management of study and nonclinical regulatory activities
  • Lead, coach and further develop and established team by providing growth opportunities
  • Maintain strong relationships with partners by communicating, seeking advice, and facilitating critical business decisions
  • Drive information management strategy and continuous improvement initiatives
  • Lead and participate in cross-functional process improvement initiatives
  • Adapt to a constantly evolving, fast-paced and often ambiguous environment
  • Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an inspirational leader with these qualifications.

    Basic Qualifications:

  • Doctorate degree and 2 years of industry experience in regulated nonclinical and/or clinical trials OR
  • Master’s degree and 6 years of industry experience in regulated nonclinical and/or clinical trials OR
  • Bachelor’s degree and 8 years of industry experience in regulated nonclinical and/or clinical trials OR
  • Associate's degree and 10 years of industry experience in regulated nonclinical and/or clinical trials OR
  • High School diploma/GED and 12 years of industry experience in regulated nonclinical and/or clinical trials
  • Preferred Qualifications:

  • 6+ years’ work experience in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories
  • Knowledge and functional expertise in R&D, particularly regulatory admissions requirements and inspection management
  • Knowledge of GCP, ICH and FDA guidelines for clinical trials
  • Knowledge of GLP, FDA guidelines for nonclinical studies and regulatory document requirements for Investigational New Drug (IND) filings
  • Experience with regulatory inspections (FDA, EMEA, PMDA)
  • Evidence of strong project management skills
  • Experience with managing teams
  • Exceptional verbal and written communication skills, including scientific technical writing
  • Working knowledge of document management applications and study planning tools (eg. Planisware, SmartSheet, Tableau, Veeva platform, etc)
  • Ability to develop collaborative internal and external relationships and navigate a matrixed organization
  • Excellent interpersonal, organizational, and critical thinking skills
  • Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Apply now

    for a career that defies imagination

    In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

    careers.amgen.com

    Equal Opportunity Statement

    R&D Operations Senior Manager (Open to Remote)

    Amgen

    Thousand Oaks California

    United States

    Customer Service / Call Center

    (No Timezone Provided)

    HOW MIGHT YOU DEFY IMAGINATION?

    If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

    R&D Operations Senior Manage r (Open to Remote)

    Live

    What you will do

    Let’s do this. Let’s change the world. In this vital role you will work toward multiple goals that will enable outstanding medicines to move through the commercialization pipeline bringing therapies to patients.

    Amgen is seeking a  R&D Operations Senior Manager  to join the Research and Development Strategy and Operations organization. In this role, you will lead a team that is responsible for managing nonclinical activities and deliverables for regulatory submission. You will also be responsible for Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) inspection readiness for regulated business units, including internal bioanalytical laboratories. In addition, you will oversee the GLP Archive (storage of GPL materials) and fulfill the duties of the eData Archivist. You will be the technical subject matter expert and serve as a key resource for issue resolution, questions and best practices. To achieve this, the manager is a creative problem solver who can deliver meaningful value-driven results that keenly drive productivity and efficiency.

    You will be part of the larger corporate mission of bringing medicines to patients with unmet medical needs every day. Our scale is global and supports our nonclinical and clinical trials around the world. Please join an outstanding team that delivers for our partners!

    Key responsibilities include, but are not limited to:

  • Collaborate closely with R&D Compliance and the regulated (GLP/GCP) business areas to ensure a compliance-focused environment in preparation for regulatory inspections and audits
  • Facilitate inspection management activities by supporting business areas during inspections and audits
  • Accountable for maintenance of GLP Archive in accordance with GLP regulations and retention strategy
  • Manage a team of professionals responsible for end-to-end project management of study and nonclinical regulatory activities
  • Lead, coach and further develop and established team by providing growth opportunities
  • Maintain strong relationships with partners by communicating, seeking advice, and facilitating critical business decisions
  • Drive information management strategy and continuous improvement initiatives
  • Lead and participate in cross-functional process improvement initiatives
  • Adapt to a constantly evolving, fast-paced and often ambiguous environment
  • Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an inspirational leader with these qualifications.

    Basic Qualifications:

  • Doctorate degree and 2 years of industry experience in regulated nonclinical and/or clinical trials OR
  • Master’s degree and 6 years of industry experience in regulated nonclinical and/or clinical trials OR
  • Bachelor’s degree and 8 years of industry experience in regulated nonclinical and/or clinical trials OR
  • Associate's degree and 10 years of industry experience in regulated nonclinical and/or clinical trials OR
  • High School diploma/GED and 12 years of industry experience in regulated nonclinical and/or clinical trials
  • Preferred Qualifications:

  • 6+ years’ work experience in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories
  • Knowledge and functional expertise in R&D, particularly regulatory admissions requirements and inspection management
  • Knowledge of GCP, ICH and FDA guidelines for clinical trials
  • Knowledge of GLP, FDA guidelines for nonclinical studies and regulatory document requirements for Investigational New Drug (IND) filings
  • Experience with regulatory inspections (FDA, EMEA, PMDA)
  • Evidence of strong project management skills
  • Experience with managing teams
  • Exceptional verbal and written communication skills, including scientific technical writing
  • Working knowledge of document management applications and study planning tools (eg. Planisware, SmartSheet, Tableau, Veeva platform, etc)
  • Ability to develop collaborative internal and external relationships and navigate a matrixed organization
  • Excellent interpersonal, organizational, and critical thinking skills
  • Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Apply now

    for a career that defies imagination

    In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

    careers.amgen.com

    Equal Opportunity Statement