Manhattan WMOS Engineer
ShyftLabs
Support Manhattan WMOS implementations and operations as a WMS Engineer at ShyftLabs. ShyftLabs builds data products and digital solutions for Fortune 500 companies.
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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, Oncology Regulatory Liaison
Lead regulatory strategy and agency engagement for oncology products at MSD. Support global registrations, lifecycle management, submissions, and compliant product development.
संयुक्त राज्य
मैसाचुसेट्स
न्यू जर्सी
पेंसिल्वेनिया$1,29,000 – $2,03,100 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालनविवरण
- Support oncology products within a regulatory affairs team
- Partner with global regulatory leads on registration and product-maintenance strategies
- Contribute to marketing applications, IND submissions, pediatric plans, and annual or periodic reports
- Track, draft, coordinate, and review responses to regulatory agency requests
- Prepare agency background packages and marketing application documents
- Communicate with regulatory agencies and participate in agency meetings as needed
- Contribute to global regulatory teams and cross-functional meetings
- Evaluate regulatory guidance, precedents, and competitive intelligence
- Help prepare regulatory strategy documents
- Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, clinical research, and non-clinical safety teams
- Support quality compliance and lifecycle management for oncology programs
- Contribute to label development
- Support regulatory process improvement initiatives
- Handle regulatory administrative activities as needed
आवश्यकताएँ
- Bachelor’s degree and at least 5 years of relevant pharmaceutical industry experience, or a master’s degree and at least 2 years of relevant experience, or an M.D., Ph.D., or related doctorate in biological science, chemistry, or a related discipline with relevant experience
- Experience with drug development
- Previous regulatory experience involving interaction with a major regulatory agency
- Excellent written and verbal communication skills
- Strong organization and the ability to manage varied activities across multiple projects simultaneously
- Flexibility
- Strong scientific and analytical capabilities with close attention to detail
- Oncology product experience is highly preferred
- Eligibility to reside in the United States and Puerto Rico
- Visa sponsorship is not available
- Willingness to travel up to 10%
- A valid driving license is not required
लाभ
- Annual bonus
- Long-term incentive, where applicable
- Medical, dental, and vision coverage
- Additional insurance benefits for employees and families
- Retirement benefits, including a 401(k) plan
- Paid holidays
- Vacation leave
- Compassionate leave
- Sick leave
- Hybrid work arrangement
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