R&D Operations Sr Mgr (US-Remote)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
R&D Operations Senior Manager
What you will do
Lets do this. Lets 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 aR&D Operations Senior Managerto 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
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.
- Doctorate degree and 2 years of industry experience in regulated nonclinical and/or clinical trials OR
- Masters degree and 6 years of industry experience in regulated nonclinical and/or clinical trials OR
- Bachelors 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
- 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
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
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.
Join UsIf 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.
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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.