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Company

Original Job Post

BioSpace · 3 days ago

R&D Supplier Governance Manager

Thousand Oaks, CA

Full-time

Hybrid

Mid, Senior Level

7+ years exp

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H1B Sponsorship

Comp. & Benefits

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Responsibilities

An SME in imaging modalities

Partnering with Clinical Research Medical Directors (CRMDs), Global Trial Manager (GTMs), Imaging Scientists, RDSG governance teams, and imaging suppliers

Understanding the imaging modality needs for the study and the suppliers capabilities to meet the needs

Developing a standard end to end process for imaging and integrate into wider clinical development procedures

Focusing on Imaging and Adjudication supplier relationships

Attending supplier governance meetings and participating in operating reviews

Developing effective partnerships with suppliers

Supporting business functions with selection and development of new suppliers

Identifying business needs at Amgen for new suppliers with functional input

Advising in sourcing activities

Supporting final decision on selection of suppliers

Identifying functional standard methodologies and process improvements and coordinate their development and implementation for suppliers by

Communicating and standardizing best practices across supplier types

Ensuring adherence to best practices by Amgen functional areas

Collaborating closely with functional areas to ensure internal business needs are being met

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Doctorate degreeMasters degreeAssociates degreeNuclear medical technicianImaging modalitiesOncology StudiesClinical StudiesDrug DevelopmentBiotechPharmaceuticalProject ManagementLife SciencesBiopharmaceuticalClinical Trials Clinical PracticesFDA RegulationsRegulatory RequirementsProject PlanningScientific WritingProblem-SolvingInterpersonalOrganizationalSupervisoryCollaborationLeadership

Required

Doctorate degree

Masters degree & 2 years of direct experience with imaging modalities

Bachelors degree & 5 years direct experience with imaging modalities

Associates degree & 10 years direct experience with imaging modalities

Nuclear medical technician & 10 years direct experience with imaging modalities

Preferred

Knowledge and working experience of different imaging modalities

Knowledge and working experience of read criteria in oncology studies

Experience in clinical studies, drug development, biotech and/or pharmaceutical

Project management of imaging studies

BA/BS/BSc in the sciences or RN

7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical trial experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines

Project management/project planning experience

Proficiency in anticipating and resolving problems

Experience writing and communicating clearly on scientific and clinical issues

Excellent interpersonal, organizational, supervisory skills

Professional collaboration and leadership skills

Benefits

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

Company

BioSpace

BioSpace is the leading online community for industry news and careers for life science professionals.

Founded in 1988

San Francisco, California, USA

11-50 employees

http://www.biospace.com/

H1B Sponsorship

BioSpace has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2020 (2)