What you will doIn 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 youBasic 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
ThriveWhat you can expect of usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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 positionAmgen 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.
