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At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments. ​​

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🔥 ServiceNow Platform Administrator
Posted 1 day ago

📍 United States

🧭 Regular

  • Five plus years of proven experience as a ServiceNow Administrator or in a similar role.
  • Strong understanding of ServiceNow platform capabilities and best practices.
  • Excellent problem-solving skills and the ability to work collaboratively across teams.
  • Familiarity with ITIL or similar frameworks is a plus.
  • Strong communication skills, both verbal and written.
  • Manage access to the ServiceNow platform and oversee overall platform security.
  • Monitor platform performance, including incidents, changes, and requests and reports.
  • Complete work assigned including simple configurations, dashboard and report creation, and notification updates.
  • Oversee the Managed Service provided and act as Tier II subject matter expert to evaluate and recommend optimal solutions.
  • Participate in all sprint-related ceremonies, including Sprint Planning, Sprint Retrospective, and Backlog Review.
  • Provide guidance on work prioritization and development/configuration architecture and design feasibility.
  • Oversee all platform updates according to a defined release schedule.
  • Lead upgrade, patching, and cloning activities for the ServiceNow environment.
  • Manage the impact relationship with ServiceNow, ensuring optimal performance and issue resolution.
  • Lead the development team, providing support, direction, and feedback on processes and improvements.
  • Perform a quarterly evaluation of the platform to assess performance and utilization.
  • Conduct licensing reviews and assess utilization metrics.
  • Attend daily standups to discuss platform status and ongoing tasks.
  • Drive escalations with ServiceNow or appropriate teams, as necessary.
  • Oversee knowledge management activities related to the ServiceNow application.
  • Create and update existing platform documentation to ensure knowledge retention.
  • Drive the team to fix security issues, as applicable.
  • Execute compliance-related activities, including updates to Admin SOPs, WI, PPR, DR Attestation, Inspection Readiness, Access Review, BTCARES, and Data Certification.
  • Complete access approvals, change approvals, and ETQ approvals.
  • Collaborate with leadership on platform strategy and organizational goals.
  • Meet with product owners to resolve issues and enhance team relations and cross-collaboration.
  • Provide feedback on contingent worker resources and monitor platform health.
  • Watch for ServiceNow communications to understand potential impacts to the platform and ensure risks are properly mitigated.
  • Serve as an escalation point for unresolved platform issues and propose new standard changes, where feasible.
  • Participate and guide CMDB governance activities to ensure data integrity and compliance.

LeadershipSQLAgileSCRUMCI/CDComplianceChange Management

Posted 1 day ago
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🔥 Associate Director, Clinical Pharmacology
Posted 4 days ago

📍 United States

🧭 Regular

💸 113500.0 - 193300.0 USD per year

🔍 Biotech

  • Extensive working knowledge of small molecule drug development, with specific expertise in translational medicine and clinical pharmacology principles including pharmacometrics, drug metabolism and human ADME, biomarkers, exposure-response assessment, and biopharmaceutics.
  • Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, and clinical pharmacology as disciplines to facilitate clinical development of drug candidates or in the assessment of business development opportunities
  • Good working knowledge of regulatory guidances and requirements pertaining to early clinical development including clinical pharmacology guidelines and principles, exposure-response analysis guidances and principles pharmacokinetic and pharmacodynamic modeling (including population pharmacokinetic modeling), nonclinical guidelines and principles, biopharmaceutics guidelines, other clinical development guidances, as appropriate.
  • Working knowledge of GCP, ICH and other regulatory standards.
  • Ability to understand and interpret clinical and scientific information and data and communication thereof in written or oral form appropriate for the receiving audience.
  • Skillful at technical writing with an ability to clearly and accurately summarize clinical and scientific information in written format.
  • Track record of effective functional representation on product development teams.
  • Excellent verbal and written communication skills.
  • Collaborative mindset with a positive, transparent and inclusive approach as a representative or leader of cross-functional team(s).
  • Functional capability with various software platforms including Microsoft Word, PowerPoint, Excel.
  • Ensure early development plans incorporate a biomarker strategy and leverage PK/PD modeling to establish an exposure-response relationship that optimizes dose selection, facilitates the efficiency of the overall program development plans and enables fastest to market opportunities.
  • Represent the Clinical Pharmacology function or serve as subject matter expert for translational medicine and clinical pharmacology on ADTs responsible for devising and executing on the EDP (TMED scope: first-in-man to Phase 2a), late-stage development plans or, for mature or commercial assets, LCM plans.
  • Participate in or lead ADT sub-team meetings, as appropriate.
  • Responsible for the design, execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with the program plans and serve as an active member of the clinical study team.
  • Provide input to vendor selection and provide vendor oversight and management for TMED studies, in collaboration with the TMED operations lead, bioanalytical or modeling leads, procurement and clinical business operations or other internal cross-functional partners, as appropriate.
  • Responsible for authoring translational medicine and clinical pharmacology components of TMED study protocols, clinical study reports, Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents.
  • Provide clinical pharmacology subject matter expertise and lead the authoring of responses to health authority questions and inquiries.
  • Author the translational medicine and clinical pharmacology components of study protocols, clinical study reports, Investigator Brochures, briefing books and other regulatory documents such as IND subsections and submission modules.
  • Participate in health authority meetings, as necessary.
  • Prepare presentations TMED plans for governance meetings.
  • Attend and actively participate in assigned asset development and sub-team meetings, clinical study team, modeling and vendor meetings.
  • Contribute to scientific communication and events.
  • Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.

Data AnalysisGCP

Posted 4 days ago
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