Nda jobs in massachusetts

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 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

Scientific Director, Pathology

Boston, Massachusetts

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Today

By clicking the ?Apply? button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda?s and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: This role provides scientific and strategic leadership to embed AI/ML-enabled pathology and digital pathology capabilities into Takeda?s n

Full-time

Compensation information provided in the description

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

Director, Quantitative Clinical Pharmacology (QCP) Lead

Boston, Massachusetts

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Today

By clicking the ?Apply? button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda?s and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Quantitative Clinical Pha

Full-time

Compensation information provided in the description

Sr. Process Development Engineer - OSD

Waltham, Massachusetts

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Today

Job Description Join the Alkermes Process Development team as Senior Engineer, where you will provide technical leadership and support the development of innovative small molecule pharmaceutical dosage forms. You will operate within cross functional teams to ensure alignment during drug product development, join the CMC teams, and provide leadership for development teams. You will design and execute experimental studies to develop well understood, robust oral solid dosage manufacturing processe

Full-time

USD 140,000.00 - 154,000.00 per year

Fall 2026: Product Design Engineering Co-op, Advanced Development (July/August to December)

Needham, Massachusetts

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Today

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains.

Full-time

USD 30.00 - 36.00 per hour

Sr. Director, Head of Process Engineering

Cambridge, Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVE: Synthetic Molecule Process Development (SMPD) is responsible for developing robust, sustainable, and cost-effective proces

Full-time

USD 212,000.00 - 333,190.00 per year

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

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

Nda jobs in Massachusetts, USA