Biomedical Data Stewardship Senior Manager

1 week ago

Washington DC, United States Amgen Full time

What you will do

In this role we are looking for individuals with medical or regulatory writing background, and a passion for drug development. The candidate for this role will work within the Biomedical Data Stewardship (BMDS) team at Amgen. This role will have an opportunity to work across Amgen’s pipeline to participate in and lead the creation, maintenance, extraction, consolidation, and presentation of protocol data standards. The role will provide opportunities to develop leadership skills and utilize standardization methods to drive clinical development strategy.

In this role you will:

  • This role is responsible for overseeing the creating TA specific preferred protocol libraries

  • Development and oversight of timelines and resource projections for library development

  • Train and mentor medical writers as required, review their work and provide guidance as to necessary and suggested changes

  • Oversee meetings with the TA SMEs to review and revise the libraries during development

  • Oversee the review of libraries within the TA during development

  • Participate in final review of each library

  • Oversee edits to the library as needed immediately after release

  • Oversee the development and delivery of training on the library immediately after release

  • Oversee hypercare sessions immediately after release

  • Ownership of half of the libraries

  • Edits to the library as needed

  • The development and delivery of additional training on the library as needed

  • Protocol review to make sure libraries are used properly

  • Development of additional libraries as needed

What we expect of you

Basic Qualifications:

  • Doctorate degree and 2 years ofclinical experienceORMaster’s degree and 4 years of clinical experienceORBachelor’s degree and 6 years of clinical experienceORAssociate’s degree and 10 years of clinical experienceORHigh school diploma / GED and 12 years of clinical experience

Preferred Qualifications:

  • Master’s degree with relevant experience

  • Good understanding of clinical trials

  • Thorough knowledge in Microsoft Office, Teams, Excel and SharePoint

  • Experience with document formatting and authoring templates

  • Experience working with pharmaceutical industry

  • Excellent written/oral communication skills and attention to detail

  • Strong Leadership in a team environment

  • Proven project leadership experience

  • Independent and self-motivated

  • Strong organizational skills such that facilitate multi-tasking in time-sensitive environments

  • Strong communication and collaboration skillsAble to work with strategic deadlines and adapt quickly to changing requirements and priorities

Thrive

What you can expect of us

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

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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

Amgen is an Equal Opportunity employer and will consider you without regard to your 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.

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