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​​Manager, Is Rncd Systems Operations​ (Remote)

5+ years
$117,600.00 - $176,400.00
10 Dec. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Here’s the rewritten job description with the slug included:


Manager, IS RNCD Systems Operations​ (Remote)
Req ID: R009964
Location: Philadelphia, PA [Remote/Home-Based]
Category: Information Services


About Jazz Pharmaceuticals
Jazz Pharmaceuticals (NASDAQ: JAZZ) is a global biopharmaceutical company dedicated to transforming the lives of patients and their families. We focus on developing life-changing medicines for serious diseases with limited or no therapeutic options. Our diverse portfolio includes marketed medicines and novel products in neuroscience and oncology. We are passionate about innovation, exploring new options for patients through novel compounds, small molecules, biologics, and cannabinoid science. Jazz is headquartered in Dublin, Ireland, and serves patients across nearly 75 countries worldwide.


Position Overview
The Manager, IS RNCD Systems Operations will facilitate the day-to-day operations of Jazz’s Research and Nonclinical Development (RNCD) business functions. This includes managing the creation, review, and maintenance of operational plans and validation deliverables, overseeing routine system upgrades and enhancements, and ensuring system compliance with Jazz’s operational standards. This role requires a deep understanding of Research and Discovery applications and systems to effectively support business functions and collaborate with cross-functional teams, such as Compliance, QA, and InfoSec.


Essential Functions/Responsibilities

  • Collaborate with Business Process Owners and IS RNCD Capability Enablement Leads to maintain and upgrade various RNCD applications.
  • Manage system operations and run management, working closely with Jazz RNCD business functions and third-party vendors.
  • Follow Jazz GxP change management procedures to resolve issues, implement system requests, and conduct validation testing.
  • Create, update, and manage operational and system documentation (GxP/Non-GxP) and test scripts.
  • Partner with vendors, IS Business Partner Leads, and other R&D functions to address system defects and align technology with business processes.
  • Plan and execute routine system owner activities such as user access reviews, system upgrades, disaster recovery testing, license management, and systems roadmap development.
  • Manage project aspects including scope, resource allocation, and budgets.
  • Collaborate with IS, Quality, and other teams to balance risk mitigation, operational assurance, and validation for Jazz systems.
  • Support the transition of new systems from implementation to operations in collaboration with IS Business Partner Leads.

Required Knowledge, Skills, and Abilities

  • In-depth knowledge of RNCD systems, including Biovia ELN, Tibco Spotfire, Sample Management, Gastroplus, and others.
  • Experience in GxP validation and operational assurance documentation, such as URS, FRS, data migration protocols, and disaster recovery plans.
  • Proven experience in IS system ownership and operations management.
  • Ability to prioritize support activities and manage operational needs independently.
  • Experience with cloud computing, SaaS, PaaS, and web-based technologies.
  • Strong written and verbal communication skills, with the ability to work effectively in a fast-paced environment.
  • Strong analytical skills and troubleshooting ability.
  • Excellent organizational skills and attention to detail.
  • Experience working in a regulated GxP environment is desired.
  • Experience with managed services provider (MSP) oversight is a plus.

Required/Preferred Education and Licenses

  • Bachelor’s degree (B.A. or B.S.) from a four-year accredited institution, with 4-6 years of relevant experience or equivalent education and experience.

Physical Demands

  • Occasional mobility within the office environment.
  • Routine sitting for extended periods.
  • Frequent use of computer and office machinery.
  • Some travel may be required for work-related duties.

Work Environment

  • Office environment with minimal exposure to noise, dust, fumes, vibrations, and temperature changes.
  • Frequent computer use and occasional movement between work locations.
  • May require flexible work hours to meet business needs.

Compensation
The full base pay range for this role is $117,600.00 - $176,400.00 for US-based candidates, dependent on qualifications, experience, and other factors. Compensation may also include discretionary annual cash bonuses, equity grants, and various benefits like medical, dental, vision insurance, 401(k), and flexible paid vacation. For more details on our benefits offerings, visit here.


Equal Opportunity Employer
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, veteran status, or any characteristic protected by law.