Clinical Compliance Specialist- San Diego based

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 leading 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, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, 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 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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Supports study teams on audit/inspection-related activities, by providing guidance on findings and escalating to Clinical Compliance (CC) Sr. Specialist(s), Managers and Directors as needed

• Acts as ClinOps liaison by providing guidance on clinical processes and Good Clinical Practices (GCP)

• Supports creation and revision of ClinOps controlled documents by generating initial drafts, consolidating comments and scheduling meetings with Subject Matter Experts (SMEs)

• Maintains NBI consent documents templates, and associated documents

• Supports study teams on SST activities, including maintenance of SST matrix templates, processing of document submissions for SST assignment

• Assists ClinOps training activities under direction of CC Sr. Specialist(s), Manager(s) and Director(s) (e.g., scheduling live training sessions, managing training records, drafting and distributing training materials)

• Manages CC mailbox, redirecting inquiries to CC Sr. Specialist(s), Manager(s) and Director(s), as needed

• Manages applicable distribution lists (e.g., internal distribution of safety reports from NBI Drug Safety and Pharmacovigilance to study teams)

• Supports ClinOps training curricula review (e.g., retrieves reports for current assignments, obtains current job descriptions, schedules meetings with group leads)

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

• Provides administrative support, including maintenance of CC tools, authoring meeting minutes, and creating reports

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

• Demonstrates knowledge of applicable regulatory requirements, and business standards. Constantly maintains knowledge in an on-going manner

• Performs other duties as assigned

• BS/BA degree in life science or related field or RN and 2+ years of clinical trial experience working at a biotech/pharmaceutical company, CRO, or clinical site OR

• Master's degree in life science or related field and Some experience as noted above

• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers

• Has experience in specific functional discipline while working to acquire higher-level knowledge and skills

• Comfortable with tools and processes that support work conducted by functional area

• Detail oriented

• Good project management skills

• Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive

• Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out

• Able to work independently and to function as a team player

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

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Must have excellent interpersonal skills and excellent communication skills (verbal and written)

• Computer proficiency with MS Office

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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.

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