Associate Specialist, Document & Clinical Systems

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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• Perform data entry and reconciliation in various clinical systems and tracking tools

• Perform secondary quality check (QC) for documents submitted to the TMF

• Provides support to study team including, but not limited to, maintenance of documentation, clinical tracking and information retrieval.

• Assist with the organization of the controlled clinical document storage on-site

• Assists with off-site archiving activities (including cataloguing process and document retrieval).

• Assist the Sr. Specialist with documenting the set-up, review, maintenance and archival of study specific TMFs in TMF Plans and study specific TMF Index. Plans may include TMF transition and/or migration activities

• Work with study team to ensure "inspection readiness" at all times

• Perform additional tasks and duties as assigned

• BS/BA degree in life science or related field or RN and with some relevant experience working directly with clinical trial documentation working at a biotech/pharmaceutical company or CROOR

• High School diploma andMinimum of 4 years of clinical support experience with essential regulatory documents

• Understands Neurocrine's business objectives and develops 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 interpersonal, organizational, communications, problem-solving, analytical thinking skills

• Detail oriented

• Ability to meet deadlines

• Good project management skills

• Working knowledge of clinical study documents and managing Trial Master Files in Clinical Systems (eTMF and CTMS - Veeva preferred).

• Ability to process, archive, and retrieve documents in electronic format.

• Working knowledge of clinical trials

• Good computer 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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