Associate Specialist, Clinical Compliance

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than 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. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

Facilitates Clinical Compliance operational activities, manages the Study-Specific Training (SST) process, and assists with process improvement initiatives under the guidance of the Clinical Compliance Specialist, Manager, or Director.

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Your Contributions (include, but are not limited to):

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

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

  • Plans and schedules CC meetings and training sessions

  • Coordinates training recording activities

  • Manages training records

  • Drafts training materials

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

  • Compiles metric reports

  • Administers email distribution lists

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

• Manages the Study-Specific Training (SST) activities, including maintenance of SST matrix templates and processing document submissions for SST assignments

• Participates in and promotes collaboration during 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

Requirements:

• BS/BA degree AND Some experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Assistant/Associate, or equivalent, preferred

• Applies general knowledge of business developed through education or experience and begins to learn Neurocrine's business

• Has basic knowledge of practices and procedures within own discipline

• Developing skill and abilities with tools used in the job family or discipline

• Has conceptual knowledge of theories and practices and will learn procedures within own functional area

• Ability to work as part of a team

• Good computer skills

• Developing communications, problem-solving, analytical thinking, planning