Sr. Clinical Compliance Manager

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.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 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, classic congenital adrenal hyperplasia, 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 onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Ensuring clinical study activities are conducted in compliance with FDA regulations, ICH guidelines, and NBI SOPs

• Developing SOPs, process documents, and templates for Site Monitoring Plan, Trial Master File (TMF) Plan, Study Reference Manual, Visit Report Annotations, forms, and tools

• Training NBI Clinical Operations personnel on clinops processes

• Developing and executing training program for onboarding of new CRAs

• Collaborating with Regulatory Affairs regarding IRB submission processes across programs

• Liaison with CRO across functional groups at NBI and CRO to establish plans and procedures for study conduct

• Developing plans and documenting processes for NBI and CRO studies to ensure complete story of trial can be related once at the completion of the trial and for future regulatory inspections

• Developing Study Start Up activities including essential document collection and review, IRB approval and consent development across NBI programs

• Creating and serving as cross functional Head of TMF Steering Committee ensuring study documentation is appropriately and consistently filed across NBI programs and departments

• Incorporating Risk Based Monitoring with Clinical Quality Assurance counterparts to assure subject safety and data integrity across NBI Development Programs

• Performs other duties as assigned

• BA/BS degree in life sciences or related field and 8+ years of clinical experience in pharmaceutical industry/ Biotech or CRO. Experience with clinical drug development process including working knowledge of ICH, GCPs, and FDA regulations. Experience with global regulatory Document management requirements. Experience with electronic document management software (e.g. Veeva), OR

• Master's degree in life sciences or related field or RN and 6+ years of similar experience note above

• Requires expertise of the clinical drug development process including working knowledge of ICH, GCPs, and FDA regulations

• Clinical study management experience across all phases of clinical studies

• Strong computer/IT skills, organizational skills, interpersonal and team participation skills are essential

• Effectively operates in multi-level matrix environment

• Anticipates business and industry issues; recommends relevant process / technical / service improvements

• Demonstrates broad expertise or unique knowledge

• Considered an expert within the company and may have external presence in area of expertise

• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team

• Ability to work as part of and lead multiple teams

• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on division/company

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.

• Excellent project management, strong project leadership skills

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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.

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