Instagram
youtube
Facebook

Senior Specialist

2+ years
Not Disclosed
10 July 23, 2024
Job Description
Job Type: Full Time Education: BS/MS in chemistry, biology, data science or other scientific discipline Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary As a Senior Specialist in ORE, you will support the outsourcing process for scientific activities within BR functions and projects. You will manage operational aspects of the outsourcing workflow, maintain CRO relationships, and ensure the generation and internalization of high-quality data.

About the Role Major Accountabilities:

  • Manage the operational aspects of CROs supporting Novartis BR scientific functions and projects under the supervision of ORE team members.
  • Drive efficient, cost-effective, high-quality infrastructure and logistics for outsourcing scientific activities, including invoice reconciliation, sample retention logistics, data QC, process automation, and scientific material stewardship.
  • Act as the scientific contact for the operation and logistics of outsourcing requests.
  • Collaborate with scientific functions to ensure assay performance and data QC.
  • Gather input and provide recommendations for optimizing resource allocation; identify issues and propose mitigating plans.
  • Develop tools for data handling and processing, such as data QC and analysis.
  • Ensure adherence to BR compliance and operational policies.

Ideal Background Education:

  • BS/MS in Chemistry, Biology, Data Science, or other scientific disciplines.

Languages:

  • English

Experience:

  • Minimum 2 years of experience in pharmaceutical or biotech research.
  • Expertise in areas such as in vivo PK, in vitro ADME, preclinical safety profiling, biochemical and cellular assays, NGS, biologics, customs & shipping logistics, with a strong background in data analytics.
  • Experience in data analytics, process automation, and database applications