At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. *in collaboration with AbbVie

Supports Clinical Compliance operational activities and manages Study-Specific Training (SST) process.

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Your Contributions (include, but not limited to):

• Supports Clinical Compliance (CC) team on operational tasks:

  • Creates and maintains CC tools (e.g., trackers)

  • Schedules CC meetings and training sessions

  • Coordinates training recording activities

  • Manages training records

  • Drafts training materials

  • Initiates CC documents (e.g., templates)

  • Creates metric reports

  • Manages email distribution lists

  • Manages CC mailbox and redirects inquiries to CC Specialists, Managers, and Directors, as needed

• Manages the SST activities, including maintenance of SST matrix templates and processing of document submission for SST assignment

• Participates and promotes collaboration in departmental and cross-departmental meetings, as necessary

• Develops and maintains working relationships with other functional areas outside of Clinical Operations

• Performs other duties as assigned

• BS/BA degree in life science or related field or RN and Preferred some relevant experience in clinical research or medical field

• Some knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs)

• Some knowledge of Clinical Operations

• Some trial management protocol and process knowledge

• General understanding of Clinical Research industry and the relevant environments in which it operates

• Clinical terminology and GCPs knowledge

• Basic knowledge and understanding of applicable regulatory requirements

• Ability to work as part of a team

• Good computer skills (MS Office, Smartsheet, SharePoint)

• Developing communications, problem-solving, analytical thinking, planning and organization skills

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.