- Sanofi Group (Morristown, NJ)
- **Job Title:** Strategic Initiative Lead - Regulatory Data, Digital and AI **Location** : Cambridge, MA or Morristown, NJ **About the Job** Do you thrive ... the intersection of regulatory expertise and digital innovation? As the Strategic Initiative Lead , you will turn bold ideas into validated opportunities,… more
- Sanofi Group (Morristown, NJ)
- … impact assessments for proposed product changes + May serve as a regional/local regulatory lead and point of contact with medical deviceHealth Authorities for ... for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the additional… more
- Merck (Rahway, NJ)
- …have excellent communication and collaboration skills and will work closely with a global regulatory lead (s) to help develop and implement a global strategy for ... attending Agency meetings as needed to assist the global regulatory lead . + Participating as an active... in label development. + Assisting with process improvement initiative . + Performing regulatory administrative activities, as… more
- Merck (Rahway, NJ)
- … Documents, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Stakeholder Engagement, Strategic Thinking, Systems Development Lifecycle ... **Job Description** **Associate Director, Regulatory Submissions Archive Operations** Location: Rahway, NJ (Hybrid...platforms (eg, eTMF) for migration and record alignment. + Strategic Leadership + Support GRACS' long-term strategy to unify… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …functions (Clinical, Pre-Clinical and Discovery Research) for selected preferred suppliers. Lead strategic executive level governance for selected preferred and ... Readiness In collaboration with GXP Quality, R&D and Tech Ops Business partners, lead the strategic sourcing support for supplier selection, qualification and… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com **Job Function:** Marketing **Job Sub** **Function:** Strategic Marketing **Job Category:** Professional **All Job Posting Locations:** ... Johnson & Johnson is recruiting for a **Manager, Portfolio Strategy - Global Strategic Marketing, J&J MedTech Surgery MTST** located at our Raritan, NJ site… more
- Merck (Rahway, NJ)
- …3 DAYS PER WEEK) The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+… more
- Merck (Rahway, NJ)
- …development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality ... **Job Description** **Associate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent)** _Our company's Device Product & Process… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Outcome Assessment (COA) Lead **Grade:** L3 **Hiring Manager:** Benoit Arnould **Location** : Cambridge, MA or Morristown, NJ (Hybrid policy ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Bristol Myers Squibb (Princeton, NJ)
- …Program Leads within the ICV Global Program Leadership organization are strategic -thinking, problem-solving, and action oriented scientific leaders who bring drug ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready ... with a less traditional background. **Job Description** The Group Lead , Supply Chain CoE - North America will ...practices and competitors. **5. Program Management Office (PMO) & Initiative Deployment** - Oversee PMO functions to ensure successful… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our ... and business stakeholders to drive measurable business value. **Key Responsibilities** + Lead the strategy, architecture and roadmap for SAP Finance for our… more
- S&P Global (Princeton, NJ)
- …and growing the Credit Solutions business and in mitigating operational, financial, legal and regulatory risks. The Licensing Analysis Lead will play a key role ... with the ability to collaborate with commercial, legal, and regulatory teams; and guide and mentor team members +...to return to work? As part of our Return-to-Work initiative , we are encouraging enthusiastic and talented returners to… more
- Bristol Myers Squibb (Madison, NJ)
- … documents for submission across several markets * Ability to lead strategic framework for clinical sections of regulatory documents * Exceptional clinical ... cell therapy. The incumbent will be accountable, alongside the Clinical Development Program Lead , for the development of differentiated and strategic CDPs from… more
- Merck (Rahway, NJ)
- …support for related drug/vaccine projects in Late Development Statistics. + Lead the interaction with Clinical, Regulatory , Statistical Programming, Data ... specific disease area. **Primary activities** **:** + Serves as statistical representative and lead in the cross-functional teams for the strategic planning and… more
- Sanofi Group (Morristown, NJ)
- …was possible. Ready to get started? **Main Responsibilities** + Partner with the Device Regulatory Lead on assigned projects + Provide regulatory guidance ... proposed product changes + May serve as a regional/local regulatory lead and point of contact with...influencing and persuasive negotiation skills + **Soft Skills:** Demonstrate strategic thinking, initiative , change agent leadership and… more
- Merck (Rahway, NJ)
- …in cell culture commercialization and manufacturing operations + Strong understanding of regulatory requirements + Ability to lead without authority, build ... career to the next level? We are seeking a strategic and technical leader with expertise in cell culture...second generation process development and health authority licensure. You'll lead the charge in transforming our late-stage pipeline into… more
- Merck (Rahway, NJ)
- …Technical Leadership will be responsible and accountable for technical leadership, strategic planning and portfolio execution of key packaging and assembly ... will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape… more
- Merck (Rahway, NJ)
- …Center of Excellence (COE) is responsible and accountable for technical leadership, strategic planning and portfolio execution of key work in support of Centers ... combination product technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape… more
- Merck (Rahway, NJ)
- …and a robust commercial supply chain to achieve uninterrupted long-term supply + Lead DCT. Critically assesses all team deliverables & fosters a learning and ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more