Regeneron
Regeneron
Regeneron एक जैव-प्रौद्योगिकी कंपनी है जो गंभीर और उपेक्षित स्वास्थ्य समस्याओं के लिए दवाओं की खोज, विकास और व्यावसायीकरण करती है। इसका अनुसंधान एलर्जी, हृदय एवं चयापचय संबंधी रोगों, तंत्रिका-विज्ञान, कैंसर-विज्ञान, रक्त-विज्ञान, नेत्र-विज्ञान और दुर्लभ रोगों तक फैला हुआ है। जैविक अनुसंधान को उन्नत प्रौद्योगिकी के साथ जोड़कर Regeneron जटिल स्वास्थ्य देखभाल आवश्यकताओं को पूरा करने के उद्देश्य से जैविक और आनुवंशिक औषधियों पर काम करती है। रोगी देखभाल को आगे बढ़ाने के अपने व्यापक मिशन के तहत कंपनी स्वास्थ्य समानता, पर्यावरणीय जिम्मेदारी, वैज्ञानिक शिक्षा और नैतिक कॉर्पोरेट प्रथाओं पर भी जोर देती है।

Scientific Writer, Nonclinical PK/PD Regulatory

Regeneron is seeking a Scientific Writer to convert nonclinical pharmacokinetic, pharmacodynamic, and pharmacology data into regulatory documentation for drug development. The role includes preparing eCTD content and coordinating cross-functional development programs in a remote United States position.

विवरण

  • Prepare nonclinical PK/PD study reports, eCTD summaries, and Investigator’s Brochure content independently.
  • Develop integrated regulatory narratives from pharmacokinetic, pharmacodynamic, and mechanistic data.
  • Partner with scientists and cross-functional teams to interpret findings and maintain consistent PK/PD messaging.
  • Manage data collection, reviews, schedules, and stakeholder communications to deliver accurate work on time.
  • Improve writing processes through guidance, workflow refinement, and AI-supported authoring and quality control.
  • Lead scientific writing for assigned programs, including document strategy and cross-functional coordination.
  • Present complex nonclinical PK/PD and pharmacology findings as clear regulatory narratives that support development and regulatory decisions.

आवश्यकताएँ

  • Bachelor’s degree in a life sciences field.
  • An MS or PhD is preferred.
  • Relevant scientific and regulatory writing experience supporting nonclinical development programs.
  • Experience working with laboratory-generated pharmacology, pharmacokinetic, or pharmacodynamic data within a nonclinical drug development team.
  • Understanding of drug development, eCTD guidance, and ICH, FDA, and EMA/CHMP nonclinical requirements, including Modules 2.4, 2.6, and 4.
  • Experience with document authoring, review, and collaboration tools in a regulated setting.
  • The recruitment process may include background checks.
  • Be prepared to provide identity, work authorization, and education verification when requested.

लाभ

  • Annual bonuses or other incentive compensation.
  • Equity awards.
  • Pension or retirement benefits.
  • 401(k) employer matching.
  • Health and wellness programs.
  • Access to fitness centers.
  • Medical, dental, vision, life, and disability insurance.
  • Paid time off.
  • Family support programs.
  • Reasonable accommodation during recruitment when needed.

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