NDA jobs in Indiana

Clinical Research Scientist III - (Director/Assoc. Director level)

Remote or Hybrid in Parsippany-Troy Hills, New Jersey

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10d ago

Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Da

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Third Party, Contract

$100 - $110

Regulatory Operations Project Manager, Global Submissions Planning/ Management

Remote or Almont, Colorado

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Today

Description: Remote Our client seeks a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high profile molecules and lifecycle management. The role focuses on operational submission content planning for Modules 1-5, coordination of global submissions and urgent authority requests, and partnership across geographies to ensure compliance with evolving eCTD requirements. The position reports to the Head of Regulatory Operations Clinical and Publishin

Contract

Regulatory Specialist

Remote

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2d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

CTRM Subject Matter Expert

Remote

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10d ago

DAMCO SOLUTIONS INC. CTRM Subject Matter Expert Role Profile Metals & Minerals Trading, with Inventory & Warehouse Management expertise Part-time advisory role supporting a Damco client modernization engagement Remote Role CTRM Subject Matter Expert Metals & Minerals Trading (Inventory & Warehouse focus) Engagement Damco client engagement legacy ERP/CTRM modernization (discovery & proof of concept) Type Consulting / advisory assignment part-time, non-dedicated Commitment A few hours per wee

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Contract, Third Party

Depends on Experience

Crystallization Process Development Engineer - Drug Substance SMDD

Indianapolis, Indiana

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Today

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i

Full-time

USD 129,000.00 - 209,000.00 per year

Associate Director, Biostatistics & AI

Remote

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Today

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare dis

Full-time

USD 173,800.00 - 217,000.00 per year

Senior AI Engineer

Remote

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Today

Overview Systems Planning and Analysis, Inc. (SPA) delivers high-impact, technical solutions to complex national security issues. With over 50 years of business expertise and consistent growth, we are known for continuous innovation for our government customers, in both the US and abroad. Our exceptionally talented team is highly collaborative in spirit and practice, producing Results that Matter. Come work with the best! We offer opportunity, unique challenges, and clear-sighted commitment to

Full-time

USD 71,500.00 per year

Head of Clinical Data Management

Remote or New Jersey

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Today

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great P

Full-time

USD 255,000.00 - 347,500.00 per year

Lead Senior Software Engineer - Full Stack (Library of Congress)

Remote or Virginia

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Today

Lead Senior Software Engineer - Full Stack (Library of Congress) Job Number: 918 Location: Remote (Must support core business hours: 8:30 AM 5:30 PM ET) Position Type: Full-Time / Key Personnel Clearance/Eligibility: Public Trust / CUI / Moderate (No active security clearance required; must complete Library of Congress IT security training and NDA) About Ad Hoc Ad Hoc is a technology company that empowers organizations to deliver scalable, impactful digital services. Using modern, agile methods,

Full-time

USD 130,000.00 per year

Regulatory Affairs Specialist Small Molecule

Remote

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7d ago

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Advisor/Senior Advisor, Engineering, Biologics Drug Product Development

Indianapolis, Indiana

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Today

Full-time

USD 129,000.00 - 209,000.00 per year

NDA jobs in Indiana, USA