Associate Specialist, Clinical Compliance

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 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:

Facilitates Clinical Compliance operational activities, manages the Study-Specific Training (SST) process, and assists with process improvement initiatives under the guidance of the Clinical Compliance Specialist, Manager, or Director.

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

• Supports Clinical Compliance (CC) team with operational tasks:

  • Develops and maintains CC tools (e.g., trackers)

  • Plans and schedules CC meetings and training sessions

  • Coordinates training recording activities

  • Manages training records

  • Drafts training materials

  • Initiates CC documents (e.g., templates)

  • Compiles metric reports

  • Administers email distribution lists

  • Manages the CC mailbox and redirects inquiries to CC Specialists, Managers, and Directors as needed

• Manages the Study-Specific Training (SST) activities, including maintenance of SST matrix templates and processing document submissions for SST assignments

• Participates in and promotes collaboration during departmental and cross-departmental meetings as necessary

• Develops and maintains working relationships with other functional areas outside of Clinical Operations

• Performs other duties as assigned

Requirements:

• BS/BA degree AND Some experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Assistant/Associate, or equivalent, preferred

• Applies general knowledge of business developed through education or experience and begins to learn Neurocrine's business

• Has basic knowledge of practices and procedures within own discipline

• Developing skill and abilities with tools used in the job family or discipline

• Has conceptual knowledge of theories and practices and will learn procedures within own functional area

• Ability to work as part of a team

• Good computer skills

• Developing communications, problem-solving, analytical thinking, planning and organization skills

• Detail oriented

• Understands importance of meeting deadlines

• Basic knowledge of Good Clinical Practices (GCP), regulatory compliance and inspection readiness

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

• Experience with Veeva Vault preferred

• Basic knowledge of clinical operations

#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.

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The hourly rate we reasonably expect to pay is $35.35-$47.34. 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 15% 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.

Biopharmaceutical company developing therapies for neurological and endocrine disorders. Headquartered in San Diego, CA.

neurocrine.com