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Labeling Process Manager

at Amgen Inc.

Posted: 9/24/2019
Job Status: Full Time
Job Reference #: R-80987

Job Description

Career Category

Regulatory

Job Description

Amgen is seeking a Labeling Process Management, Manager to join our team and work from Amgen’s beautiful Thousand Oaks, CA campus. To learn more about this position:

As part of Global Labeling, and under the supervision of the Labeling Process Management Director, the Labeling Process Management (LPM), Manager will work with Local Amgen Affiliates within the respective region, and support the implementation of, and compliance to the Labeling process. The LPM Manager will support Labeling Strategists, Local and Regional Regulatory Affairs and the Operations organization in planning and implementing a label change within the respective countries in the region.

Key Activities:

Principal responsibilities include, but are not restricted to:

  • Review and approve timeline waivers. Enforce quality and consistency in waiver justifications.
  • Facilitate the review of Label Deviations. Enforce quality and completeness of information captured in Deviation requests.
  • Facilitate communication within Global Labeling to provide labeling advice for Response to Questions (RTQ) for global and regional markets
  • Report, track and advise on bundling of core and regional document changes to Labeling Strategists and Regulatory Affairs teams
  • Provide regional support for outsourcing of Labeling activities.
  • Support the local teams with Translation tools.
  • Guide local teams in maintaining data in the labeling tool and documents within the document management system, including clarification of processes.
  • Access, review and triage Change Controls governing the implementation of labeling changes. Support projects for changes impacting more than one core label. Work across Therapeutic Areas and provide global project management coordination
  • Manage the support of global labeling vendors to ensure established SLA’s are met (e.g. translations, Quality Control checks, etc.)
  • Represent Global Labeling in AFP initiatives
  • Maintain a state of inspection readiness for records within the Labeling tool
  • Liase with other LPM managers supporting other regions for knowledge sharing and implement any lessons learned to facilitate process quality and compliance.
  • Embody continuous improvement mindset and facilitates process robustness

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Regulatory Affairs or Process Labeling experience

OR

Bachelor’s degree and 5 years of  Regulatory Affairs or Process Labeling experience

OR

Associate’s degree and 10 years of  Regulatory Affairs or Process Labeling experience

OR

High school diploma / GED and 12 years of  Regulatory Affairs or Process Labeling experience

AND

Previous managerial experience directly managing people and/or  experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
  • Accomplish business results through teams
  • Proficiency in anticipating and resolving problems
  • Use of document management tools
  • Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
  • Time and project management skills
  • Ability to take initiative and drive results
  • Tolerance for ambiguity
  • Proficiency in anticipating and resolving problems
  • Oral and written communication and presentation skills
  • Project management

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation.  Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.  A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen



Posted 25 Days Ago

Full time

R-80987