Clinical Compliance Specialist, Clinical Operations

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 patients with 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:Supports Clinical Operations (ClinOps) on efforts related to clinical process compliance, continuous improvement, and inspection readiness activities. Key contributor to other process-related tasks (eg, study-specific training process, NBI consent document template management). Facilitate training and controlled document revisions and serves as ClinOps liaison to help identify and support resolution of procedural gaps and improved ways of working.

_

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

• 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.

• 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

Requirements:

• BS/BA degree in life science or related field AND 2+ years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Specialist or Clinical Research Coordinator, or equivalent, preferred. OR

• Master’s degree in life science or related field AND Some experience as noted above

• Demonstrated understanding of Good Clinical Practices (GCP), regulatory compliance and inspection readiness

• Strong organizational and communication skills, with the ability to work effectively in a team environment and collaborate with internal and external stakeholders

• Proficiency in maintaining controlled documents, managing training activities, and maintaining distribution lists

• Commitment to staying updated on regulatory requirements and standards in the biopharmaceutical industry

• Ability to work as part of a team and independently

• Good project management skills

• Excellent computer skills. Experience with Veeva Vault preferred

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

• 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)

#LI-RS1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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.

_

The annual base salary we reasonably expect to pay is $81,000.00-$111,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.