MSD एक वैश्विक बायोफार्मास्युटिकल कंपनी है, जो कैंसर, संक्रामक रोगों, हृदय एवं चयापचय संबंधी स्थितियों और रोकथाम-केंद्रित देखभाल जैसी प्रमुख स्वास्थ्य चुनौतियों के लिए दवाइयों और टीकों को आगे बढ़ा रही है। संयुक्त राज्य अमेरिका, कनाडा और प्यूर्टो रिको में Merck & Co., Inc. के नाम से जानी जाने वाली MSD वैज्ञानिक अनुसंधान को विकास और वाणिज्यिक विशेषज्ञता के साथ जोड़कर लोगों और पशुओं तक स्वास्थ्य सेवाओं से जुड़े समाधान पहुँचाती है।
इसका कार्य मानव स्वास्थ्य, पशु स्वास्थ्य तथा अनुसंधान एवं विकास के क्षेत्रों में फैला हुआ है, जिससे वैज्ञानिक, क्लिनिकल, वाणिज्यिक, परिचालन और कॉर्पोरेट टीमों में पेशेवरों के लिए अवसर बनते हैं। दुनिया भर के विभिन्न क्षेत्रों में अपनी गतिविधियों के साथ, MSD का करियर-केंद्रित कार्य अनुसंधान, सहयोग, समावेशन और वैश्विक स्वास्थ्य में जिम्मेदार प्रगति पर इसके ध्यान को दर्शाता है।
Associate Director, Regulatory Affairs CMC Digital Innovation – MSD Hybrid
Lead digital and AI innovation across Regulatory CMC for MSD medicines, vaccines, and animal health products. Connect research, manufacturing, and regulatory operations through automation, modern authoring, and integrated technology solutions.
संयुक्त राज्य
न्यू जर्सी
पेंसिल्वेनिया$1,42,400 – $2,24,100 / वर्ष
हाइब्रिडपूर्णकालिकमध्य स्तरवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालनविवरण
- Create digital and AI solutions that improve Regulatory CMC workflows
- Act as the subject matter expert for Regulatory CMC digital innovation and AI
- Advance AI-enabled regulatory authoring, including innovations for Module 2 and Module 3
- Develop practical job aids and identify opportunities for generative AI-assisted drafting
- Evaluate emerging AI, machine learning, and digital technologies for Regulatory CMC use
- Lead cross-functional work spanning AI authoring, process automation, regulatory intelligence, and digital transformation
- Support the CMC digital and AI operating model while aligning local initiatives with enterprise strategy
- Collaborate with Regulatory CMC Systems and Operations on digital solutions for platforms such as Veeva
- Own designated digital tools and platforms, including the ERA App
- Monitor CMC digital priorities and communicate progress
- Work across research, manufacturing, and regulatory divisions to identify opportunities and build integrated solutions
- Promote enterprise AI adoption through champion networks, feedback channels, change management, and training
- Lead and mentor digital project teams, including GRACS CMC summer intern initiatives
- Report to the Executive Director of Regulatory CMC Digital Innovation
- Travel up to 10%
आवश्यकताएँ
- Bachelor’s degree or equivalent in a scientific, technical, or regulatory discipline; chemistry, biology, pharmacy, computer science, or data analytics preferred
- At least five years of experience in the pharmaceutical or biotechnology industry
- Strong experience in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations
- Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI or LLM solutions in a regulated business environment
- Track record of delivering enterprise solutions that improve business outcomes
- Experience with technical change management, including repeatability assessments, job aids, and training materials
- Experience mentoring and coaching colleagues or interns on digital projects and technical workflows
- Ability to collaborate effectively in a matrix organization spanning research, manufacturing, and IT
- Strong organizational and project coordination skills, with the ability to manage multiple concurrent initiatives
- Knowledge of change management, eCTD, emerging technologies, manufacturing processes, project leadership, Regulatory Affairs management, Regulatory CMC, regulatory compliance, regulatory documents, regulatory operations, regulatory reporting, regulatory strategy development, regulatory submissions, and stakeholder partnerships
- Willingness to travel up to 10%
- Must reside in the United States or Puerto Rico
- Visa sponsorship is not available
लाभ
- Annual bonus and long-term incentive, where applicable
- Medical, dental, and vision coverage
- Additional insurance benefits for employees and their families
- Retirement benefits, including a 401(k) plan
- Paid holidays
- Vacation time
- Compassionate and sick leave
- Hybrid work arrangement
- Mentorship and career development opportunities
- Relocation assistance is not provided