180 associate director medical writing jobs found

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Associate Director, Medical Writing page is loaded Associate Director, Medical Writing Apply locations Cambridge, Massachusetts Clinical Development time type Full time posted on Posted 2 Days Ago job requisition id R14688 The Role: The Associate Director of Medical Writing is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of Medical Writing. The chosen candidate will not just be a part of Moderna’s medical writing team but will lead the charge in delivering high-quality clinical and regulatory writing. From masterminding the planning and coordination to spearheading the delivery of final drafts, your role of Associate Director of Medical Writing will be pivotal. They will be the linchpin connecting the clinical development team, understanding and translating how their work shapes the broader objectives of Moderna’s clinical development program. This is not just a job, it's an...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians,...

Overview: If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Position Profile: Brief Description: The Associate Director, Medical...

We are seeking a highly skilled and experienced Associate Director, Medical Writing to join the dynamic team of our leading pharmaceutical client. This critical role involves coordinating and delivering clinical summary documents, including Integrate Director, Medical, Associate, Healthcare, Staffing, Clinical

J&J Family of Companies Associate Director, Medical Writing - Immunology Salem , Oregon Apply Now Associate Director, Medical Writing - Immunology - 2306143128W Description Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for an experienced people leader at the Associate Director level to support our Immunology therapeutic area. This position is open globally and may be located in North America (eg, Spring House, PA, Raritan, NJ, Titusville, NJ, or Canada), Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy, Poland, Bulgaria or Switzerland), or other countries. Are you ready to join our team? Then please read further! At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Janssen...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

We are seeking a highly skilled and experienced Associate Director, Medical Writing to join the dynamic team of our leading pharmaceutical client. This critical role involves coordinating and delivering clinical summary documents, including Integrated Summaries of Safety and Efficacy in eCTD format. As a "hands-on" Medical Writer, you will work with cross-functional teams and manage the preparation of various clinical documents, including clinical study reports, investigator's brochures, and drug safety-related documents. Your expertise in document management and strong word processing skills will be invaluable in this role. Some Key Responsibilities: Prepare and coordinate clinical sections of submissions in eCTD format Manage projects within defined budgets and timelines Act as a coordinator for the preparation of drug safety-related documents Review and prepare SOPs, Working Guides, and document templates Qualifications: Bachelor's degree required, advanced degree in Life...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...

Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization. The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. Must be eligible to work in the US. Job Responsibilities: Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...