Lead, AI-Driven R&D Document Standards & Submissions
BioSpace
Sanofi seeks a Lead, R&D Document Standards & Integrated Services in Morristown, NJ (and Cambridge, MA) to drive governance and standardization of regulatory documents across the global R&D organization. You will partner across Clinical, Regulatory, Quality and Digital teams to modernize templates, procedures and tools, aligning with eCTD requirements and Health Authority expectations. The role emphasizes strategic leadership, change management, and measurable delivery, with a focus on #J-18808-Ljbffr BioSpace
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Lead, AI-Driven R&D Document Standards & Submissions in Convent Station, NJ vacancy
- Lead, R&D Document Standards & Integrated Services Location: Morristown, NJ / Cambridge... ..., you will be part of our Submission & Document Services... ...immunoscience meets bold, AI‑powered research. In R&D, you... ...fast‑changing, innovation‑driven environment. Ability to manage...DocumentWork at office
$178.5k
Job Title: Modeling Lead Global HEVA (Health Economics... ...for local HTA submissions. Conceptualize advanced... ...Sanofi We’re an R&D‑driven, AI‑powered biopharma company... ...manner and to high standards of quality and rigor.... ...and use with payers. Documented experience having initiated...DocumentLocal areaWorldwide- Job title: GRA CMC Lead Location:... ...CMC Lead within our R&D team, you will manage... ...Sanofi We’re an R&D-driven, AI-powered biopharma... ...approval of supporting documents for consultation... ...define the future submission strategy; in... ...requirements, quality standards and within the time...DocumentLocal areaWorldwide
- ...Customer Data Management Lead, Payer Data Strategy &... ...and enabling data‑driven decisions across Commercial... ...Sanofi We are an R&D‑driven, AI‑powered biopharma company... ...and quality standards for Payer data at both... ...products are thoroughly documented with appropriate metadata...Document3 days per week
- ...the Global Regulatory Lead on our Global... ...immunoscience meets bold, AI-powered research. In R&D, you’ll drive... ...Sanofi We’re an R&D-driven, AI-powered biopharma... ...Strategy (GRPS), Global Submission Strategy, and core product... ...meeting briefing documents and negotiating with...Document
$148.5k - $214.5k
...Platform LeadOnsite |Lead Level|Full... ...Lead** within our **R&D team**, you will lead... ...working harmonization/standardization, validating and... ...meets bold, AI-powered research.... ...Sanofi**We’re an R&D-driven, AI-powered biopharma... ...department and deliver documents (e.g. quality...DocumentRemote workWorldwide$109k - $149.88k
...International?****Join our Mission to Lead the Future of Snacking. Make It With... ...Pride.**This is a Packaging Development R&D position in the NA Business Unit... ...Productivity and Commercialization Packaging driven initiatives.* Properly document and communicate project progress and...DocumentWork at officeLocal areaFlexible hours- ...EU, and international programs. As a key member of the Global Regulatory Team (GRT), you will provide regulatory input, lead briefing documents, manage timelines, and coordinate submissions (NDA/BLA/MAA, IND/CTA) with cross‑functional partners. #J-18808-Ljbffr BioSpaceDocument
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...Document
- ...and regulatory standards. Join the engine... ...meets bold, AI-powered research. In R&D, you'll drive breakthroughs... ...We're an R&D-driven, AI-powered... ...key trial documents protocols, informed... ...CRD and Project Lead Partner with... ...health authority submissions and contribute to...Document
- Job Title: Global Submission Manager... ...portfolio, from standard to complex. Represent... ...the Submission Lead and global colleagues... ...meets bold, AI-powered research. In R&D, you’ll drive breakthroughs... ...We’re an R&D-driven, AI-powered... ...eCTD process, document management environments...Document
$115k - $135k
...seeking a Senior Functional Lead to drive requirements,... ...Analyze and document current-state and future... ...and opportunities for standardization Define and document functional... ...training workshops Utilize AI tools to accelerate... ...preferably configuration driven systems Demonstrated...DocumentWork at officeLocal areaRemote work3 days per week$144.16k - $216.24k
Global Consolidated Customer Data & AI Lead At Bayer we’re visionaries, driven to solve the world’s toughest... ...Define and enforce global governance standards, taxonomies, data policies, and quality... ...quality, consistent structures, documented lineage, compliant usage rights,...DocumentLocal area- Consumer Experience Strategy Lead Location: Cambridge, MA About the job Sanofi is a... ...around the world. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to... ...direct and indirect team members to define, document, share and maintain our overall user...DocumentFor contractorsWork experience placementShift work
$163k - $220k
...unique position as both a leading insurance group and an... ...dedicated, embedded AI leader within our Commercial... ..., championing AI-driven transformation of workflows... ..., shapes, and documents AI use cases in partnership... ...reviews, portfolio reviews, standards development, and cross‑...Document$130k - $165k
...-up and execution, including document review, IND/CTA approval, etc... ...requirements Develop regulatory submission plans Assist with... ...maintaining the company’s quality standards Foster a collaborative team... ...Experience supporting and/or leading IND/CTA submissions Understanding...DocumentLocal area$240.94k - $291.96k
...Position Director, US Regulatory Lead, GRS Position Summary The... ...along including upcoming NDA submission. The incumbent may also serve... ...briefing packages, response documents, and correspondence with FDA.... ...compiled according to appropriate standards and guidelines. Behaviors...DocumentFull timeTemporary workRemote work- Sanofi in Morristown, NJ seeks a Global Submission Manager to oversee global regulatory submissions... ...Global Regulatory Teams, Submission Leads, and cross‑functional colleagues to plan... ...with Sanofi and health‑authority standards. Qualified candidates will have a minimum...
- Job Title AI Enablement and Adoption Lead, Strategy and Operations, Specialty Care GBU Location Cambridge, MA or Morristown, NJ (Hybrid - 3 days... ...new, AI‑enabled ways of working. About Sanofi We’re an R&D‑driven, AI‑powered biopharma company committed to improving...Work at office3 days per week
- Zelis in Morristown, NJ is seeking a Senior AIOps Leader to drive operational transformation and AWS migration. The ideal candidate will define the AIOps strategy, implementing intelligent operational patterns to enhance incident management and operational efficiency. Applicants...Flexible hours
- ...Reporting to General Manager, the Shift Lead supervises fellow coworkers while they work... ...’s high performance, quality and safety standards and guaranteeing satisfaction. A Shift... ...integrity and security with member documents and sensitive information always. Managing...DocumentShift work
Planet Fitness
Morris Plains, NJ1 day ago $17 per hour
...A leading online marketplace for buying and selling authentic sneakers... ...a transparent and data‑driven approach, giving buyers and sellers... ...used properly. Perform and document monthly safety tailgate... ...sanitation guidelines and safety standards. Inspect areas to maintain a...DocumentHourly payTemporary workWork at officeMonday to FridayAvalon Services Group Inc.
West Caldwell, NJ1 day ago- Sanofi is seeking a Regulatory Strategist to lead the development and execution of regulatory strategies in Morristown, NJ. You will work within the R&D team to support submissions and ensure compliance with US, EU, and global requirements. The ideal candidate has a scientific...Full time
- ...Job Title Logistics Lead Location Swiftwater, PA About the Job... .... About Sanofi We’re an R&D‑driven, AI‑powered biopharma company committed... ...compliance and documentation protocols Implement backup personnel... ...Good Distribution Practice standards, and Sanofi procedures About...Contract workWork experience placementLocal areaWorldwide
Sanofi
Convent Station, NJ1 day ago $24 - $28 per hour
...LEAD MITIGATION TECHNICIAN (Crew Chief Level) Insurcomm Restoration... ...hold ourselves to the highest standard to protect our team, clients,... ..., and store salvageable items Document job progress through photos,... ...certification advancement A values-driven, collaborative team that has...DocumentHourly payFull timeLocal areaImmediate startRelocation packageInsurcomm Restoration
Denville, NJ3 days ago$80k - $100k
...emphasizes tangible deliverables and ownership in a fast-paced environment, valuing individuals who can document processes, enhance operational efficiency, and utilize AI tools effectively. The position offers a compensation range of $80,000-$100,000 along with a...Document- The Team Lead, Provider Enrollment is responsible for training... ...application completion and submission Assist in the oversight of... ...necessary provider information and documentation is completed Assist in... ...Accountability Act (HIPAA) standards Understand and comply with...DocumentWork at officeLocal area
- ...technology, offering the latest AI and machine learning-... ...of a GenAI Governance Lead at ADP. You will define clear... ...’s high ethical and legal standards. Set clear expectations and document guidelines for GenAI’s operations... ...stakeholders to adopt AI-driven governance practices...Document
- ...Gilbertsville, PA 19525 is seeking a passionate Lead Infant Teacher. At our school, we put... ...activities to uphold health and safety standards, licensing regulations and ensure their... ...enhance teaching skills Assessment and Documentation: Observe, assess and document children’s...DocumentWeekend work
The Goddard School of Gilbertsville, PA
Morristown, NJ2 days ago $120k - $165k
...Summary Regulatory Compliance Lead responsible for ensuring... ...procedures that meet regulatory standards. Advise legal, product management... ...such as regulatory summary documents, tracking sheets and... ...functional collaboration. Result‑driven project management and high‑energy...DocumentWork at officeLocal areaRemote workMonday to Friday
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Lead, AI-Driven R&D Document Standards & Submissions. Be the first to apply!
