Sr. Specialist, Clinical Documents- San Diego Based

Who We Are:

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.

What We Do:

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, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Provides strategic support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). Serves as subject matter expert for electronic TMF (eTMF) end-users and facilitates responses to audits/inspections. Collaborates closely with the Clinical Operations (CO) Study Team Members and Functional Groups as TMF System Owner.

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

• In collaboration with the CO Study Team, Vendors, Functional Group Representatives, and other Stakeholders, plans/assists the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards

• Fully documents 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

• Serves as subject matter expert for the eTMF, providing technical expertise and advice to end-users and all stakeholders. Takes a proactive role in providing a high level of service to eTMF end-users

• Provides informal review of key performance indicators related to clinical trial accuracy, timeliness, and completeness of TMFs against milestone-based projections

• Proactively informs CO Study Team Leaders and Upper Managers of deficiencies from informal reviews

• Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required

• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested

• Participates in CO Study Team meetings and eTMF QC meetings, as requested

• Writes/edits TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival

• Develops and maintains close working relationships with other functional areas outside of Clinical Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development

• Perform other duties as necessary and assigned by management

Requirements:

• BS/BA degree in life science or related field or RN and 4+ years of clinical trial experience working at a biotech/pharmaceutical company, CRO, or clinical site including a minimum of 1 year of independent monitoring experience OR

• Master's degree in life science or related field and 2+ years of similar experience noted above

• Demonstrated technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements. Constantly maintains knowledge in an on-going manner

• Knowledge of FDA regulations, Good Clinical Practices, and ICH Guidelines

• Must have excellent organizational skills and be detail-oriented

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

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

• Must have excellent interpersonal skills and excellent communication skills both verbal and written

• Understands key business drivers and uses this understanding to accomplish work

• Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas

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

• Ability to work as part of a team; may train lower levels

• Excellent computer skills

• Strong problem-solving, analytical thinking skills

• Strong project management skills

#LI-TM

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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The annual base salary we reasonably expect to pay is $106,400.00-$154,325.00. 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.