Specialist, Clinical QA Audit

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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• Investigator Search Reports (ISRs):

  • Conduct reviews of the regulatory and malpractice standing as well as the audit/inspection history of potential clinical Principal Investigators (PIs)

  • Communicate ISR results to respective internal requesting departments

  • Maintain current and accurate ISR database, including metrics for reporting

• Good Clinical Practice ("GCP") Audit Database Management:

  • Track GCP audits (e.g., vendor, clinical PI site, internal audits) to ensure compliance with company SOPs

  • Maintain current and accurate GCP audit database, including metrics for reporting

• Internal Audit Support:

  • With the guidance of the supervisor, support the development of audit plans for assigned systems in line with overall QA annual audit plans, including audit resourcing and communications to internal stakeholders as applicable

  • Assist in the audit system selection process

  • Aid in timely audit conduct, reporting, review, and closeout in accordance with Company SOPs

• QA Department Support:

  • Work to ensure compliance to regulations, guidelines, and company SOPs across the organization

  • Support all on-site regulatory inspection activities as necessary

• May work on other projects within QA not related to GCP and other duties as assigned

• RN, BSN, BS/BA degree in scientific or healthcare field and 2+ years industry experience of which 1 year must be CQA or Clinical Operations experience in drug development is preferred OR

• MS degree in scientific or healthcare field and some related industry experience

• Knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired

• Working knowledge of searching, reviewing, and implementing regulatory requirements and guidelines, including research of PI regulatory histories

• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors

• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals

• 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

• Ability to work as part of a team

• Strong computer skills

• Good problem-solving and analytical thinking skills

• Detail oriented

• Ability to meet deadlines

• Good project management skills

• Strong verbal and written communication skills are required

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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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