McKesson
McKesson

McKesson एक स्वास्थ्य सेवा कंपनी है, जो फार्मास्युटिकल वितरण, चिकित्सा आपूर्ति और स्वास्थ्य सेवाओं के क्षेत्र में काम करती है। इसका कार्य फार्मेसियों, क्लीनिकों, स्वास्थ्य प्रणालियों और मरीजों को आवश्यक उपचार उपलब्ध कराने में मदद करता है, साथ ही अधिक कुशल स्वास्थ्य सेवा संचालन और दवाओं की कमी से निपटने के लिए मजबूत प्रतिक्रिया व्यवस्था का समर्थन करता है।

कंपनी विशेष चिकित्सा सेवाओं के लिए फार्मेसी प्रबंधन सॉफ्टवेयर, परामर्श और प्रौद्योगिकी समाधान भी विकसित करती है। McKesson बायोफार्मा संगठनों के साथ काम करती है और दवा की उपलब्धता, उपचार अनुपालन, व्यावसायीकरण, डेटा-आधारित अंतर्दृष्टि और वास्तविक दुनिया के प्रमाण पर केंद्रित सेवाओं के माध्यम से ऑन्कोलॉजी और बायोफार्मा प्रैक्टिस का समर्थन करती है।

Regulatory Affairs Coordinator – Tennessee Remote

Coordinate FDA and Good Clinical Practice documentation for SCRI’s community oncology trials. Support clinical sites and sponsors with regulatory records, signatures, audits, and compliance.

विवरण

  • Coordinate regulatory compliance for industry sponsors and network sites.
  • Partner with regulatory leaders, department directors, and principal investigators to support compliance.
  • Prepare for audits and meet strict deadlines.
  • Process regulatory document signature requests using an electronic signature platform.
  • Track regulatory documents awaiting site signatures.
  • Support Clinical Operations sites and internal managers with site-level regulatory needs.
  • Set up and maintain regulatory document systems for paper and electronic records.
  • Maintain FDA- and GCP-required records for sites, studies, sponsors, and networks.
  • Check regulatory documents against local SOP requirements for format and content.
  • Keep physician credentials and other key records current.
  • Assess site requests for regulatory support and direct each issue to the appropriate resolution process.

आवश्यकताएँ

  • Associate degree required; bachelor’s degree preferred.
  • Regulatory experience preferred.
  • Customer service experience preferred.
  • Knowledge of FDA and Good Clinical Practice (GCP) regulatory documentation.
  • Ability to ensure regulatory documents meet local standard operating procedure (SOP) requirements.
  • Ability to meet strict deadlines and prepare for audits.
  • Ability to keep physician credentials and other critical compliance records current.

लाभ

  • Benefits package supporting physical, mental, and financial well-being.
  • Competitive compensation package.
  • Annual bonus or long-term incentives may be offered.
  • Equity may be included in compensation.
  • Total Rewards package.

संबंधित नौकरियाँ

Knowtion Health
Napco National

Purchasing Coordinator, Saudi Arabia (Remote)

Napco National

Coordinate purchasing operations for a manufacturing business in Saudi Arabia, from purchase orders and supplier deliveries to customs paperwork and material transfers. Support shipment clearance, invoice processing, supplier claims, and product certificate renewals.

खोलें
Artemys

IT Talent Acquisition Specialist

Artemys

Recruit IT infrastructure professionals for Artemys, a digital transformation company. Lead sourcing and hiring while contributing to employer branding initiatives.

खोलें
4M Analytics

Senior Computer Vision Algorithm Engineer

4M Analytics

Develop computer vision and machine learning systems for 4M Analytics’ subsurface utility mapping platform. Own algorithms from research through production in partnership with data engineering and product teams.

खोलें
Joom

Enterprise Customer Success Manager, Brazil (Remote)

Joom

Lead renewals, retention, and account growth for JoomPulse enterprise customers. Turn Mercado Livre and Shopee analytics into practical recommendations for marketplace sellers.

खोलें
Cyera

Regional Sales Director, Identity Security

Cyera

Lead Cyera’s Pacific Northwest sales team, grow the territory, and exceed quotas for its AI and data security platform.

खोलें
Terumo Medical Corporation

Region Manager, Terumo Interventional Systems Sales

Terumo Medical Corporation

Lead medical device sales across a North Central New Jersey region, managing field teams and hospital relationships. Drive regional revenue, sales performance, and compliant promotion of Terumo Interventional Systems products.

खोलें
Dream

Senior Program Manager, Sovereign AI (Hybrid, Israel)

Dream

Lead Dream’s Sovereign AI roadmap for government and critical infrastructure customers, coordinating research, engineering, product, launches, and AI-enabled operations.

खोलें
Claroty