Neurocrine
Associate Specialist, Clinical Compliance
US CA San Diego
Sponsorship not specified$35k-$47kDetected 1 day ago
GCPComplianceProcess ImprovementFDA RegulatoryCommunicationCollaborationProblem Solving
About the role
- Your Contributions (include, but are not limited to):
Requirements
- Basic knowledge of Good Clinical Practices (GCP), regulatory compliance and inspection readiness
- Basic knowledge of clinical operations
Nice to have
- 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
- Experience with Veeva Vault preferred
Skills
- 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
- Participates in and promotes collaboration during departmental and cross-departmental meetings as necessary
- Performs other duties as assigned
Compensation
- 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.
Company info
- 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. _
- 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 )
- to relieve suffering for people with great needs.
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