Entry level medical writer [h1.location_city]
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Entry level medical writer • usa
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The Medical Writer will primarily work on the development and delivery of high-quality documents such as Clinical protocols, protocol amendments, Investigator's Brochures (IBs), non-clinical and cl...[show_more][last_updated.last_updated_variable_days]
Description : The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced individual to serve as an integral part of the Medical Writing Team to support clinica...[show_more][last_updated.last_updated_variable_days]
A confidential healthcare organization in Raleigh is seeking a motivated.Entry-Level Medical Coder / Billing Assistant.This position offers a great pathway into the healthcare field for individuals...[show_more][last_updated.last_updated_variable_days]
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1...[show_more][last_updated.last_updated_30]
Flywheel is a communications, education and training agency that supports leading healthcare companies by developing innovative medical and science educational resources.
We partner with pharmaceuti...[show_more][last_updated.last_updated_variable_days]
The medical writer will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (...[show_more][last_updated.last_updated_variable_days]
Location : Hybrid (Malvern, PA or East Windsor, NJ - 3 days in office / 2 days work-from-home) or Remote (dependent upon your location).
Salary : Commensurate with experience.Full-Time - Monday through ...[show_more][last_updated.last_updated_variable_days]
Join a locally owned company in Vestal, NY, in business since , supporting commercial and defense firms in the development of diverse products, including subway cars, locomotives, military ships, a...[show_more][last_updated.last_updated_30]
At Astrix, we're expanding our team to support a diverse range of clients across various industries.We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partn...[show_more][last_updated.last_updated_variable_days]
Basic Overview of Role and Responsibilities : .The successful candidate will assume responsibility for the below function.
Manage the customers experience and work to ensure a happy and positive revie...[show_more][last_updated.last_updated_variable_days]
D & R is a locally owned company, in business since 1990, located in Vestal, NY.We support commercial and defense firms in the development of their products.
Those products are as diverse as subway ...[show_more][last_updated.last_updated_variable_days]
The Editor is responsible for ensuring editorial accuracy, brand consistency, and message alignment across multiple POCN products and client campaigns.
This role requires exceptional attention to de...[show_more][last_updated.last_updated_variable_days]
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global...[show_more][last_updated.last_updated_variable_days]
Entry-Level Customer Service Entry Writer I.Monday-Friday, 8 : 00 AM - 5 : 00 PM.We are a leading partner for U.Our team ensures smooth, timely, and accurate customs clearance, helping clients navigate...[show_more][last_updated.last_updated_variable_days]
Reporting directly to the Vice President of Clinical Development, the Medical Writer will be responsible for leading and executing all medical writing activities supporting Xeris' clinical programs...[show_more][last_updated.last_updated_variable_days]
Up to 40 hours a week - depending on project needs.Local candidates come onsite 2 to 3 times a week.Working with internal teams on one project at a time.
Need to be detail oriented and have time man...[show_more][last_updated.last_updated_variable_days]
Our firm has a Clinical Specialist position in based in the Greenville area for one of the fastest growing divisions of a Top Company we are looking for individuals with either clinical or Med Devi...[show_more][last_updated.last_updated_variable_days]
NASDAQ : IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling ...[show_more][last_updated.last_updated_30]
Rehab Medical is on a mission to transform lives through innovative custom mobility solutions.As one of the nation's leading providers of complex rehab technology (CRT), we've empowered over 250,00...[show_more][last_updated.last_updated_variable_days]
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Allen SpoldenNew Brunswick, NJ, United States[job_card.variable_days_ago]
[job_preview.job_type]
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[job_card.job_description]Ability to work independently and collaboratively in a team environment consisting of internal and external contributors Experience in managing multiple projects simultaneously Excellent problem-solving skills with the ability to adapt to changing priorities and deadlines. Excellent interpersonal skills and ability to work with cross-functional teams to meet business objectives. Ability to initiate and generate with limited supervision medical, regulatory, and clinical documents within a reasonable timeframe Ability to develop document templates for ongoing and future submissions depending upon the scope of the project. Ability to pivot from one project to another and multitask Ability to understand client objectives and provide feedback that supports projects and deliverables in multiple therapeutic areas Ability to move efficiently in a dynamic environment Excellent verbal and written communication and listening skills. Highly proficient with Microsoft Office. Effective time management Bilingual in Mandarin and English is not required, but will be a plus Prepares, edits, and finalizes various documents, medical and technical from non-Clinical / pre-clinical to Phase IV studies. Serves as medical writing representative on cross-functional study teams and provides guidance on document strategy and content, timelines, and resource needs Manages the document development process from start to finish which may include generating multiple draft documents and formulating final approved versions, editing, reference retrieval, as well as managing other various processes are undergone (i.e., internal & external reviews, quality checks, audits, formatting, publishing). Collaborates with cross-functional team to ensure results and statistical interpretations are accurately and clearly reflected in documents. Participates in all necessary cross-functional document development meetings (i.e., kick-off meetings, comment resolution meetings) to ensure appropriate alignment from different stakeholders. Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables. Monitors regulatory, clinical / medical, and scientific findings and conclusions ensuring key messages are clear and consistent within and across documents. Provides editorial or review support for other types of documents as requested. Maintains ongoing familiarity of US and international regulations, requirements and guidance associated with the preparation and submissions of clinical regulatory documents and scientific publications Proponent of Good Publications Practice Guidelines and understand the importance of adhering to the rules and regulations of External Scientific Professional Organizations and scientific journals. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 5+ years of clinical research experience Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven
Job Description
The Medical Writer will primarily work on the development and delivery of high-quality documents such as Clinical protocols, protocol amendments, Investigator's Brochures (IBs), non-clinical and clinical summaries together with integrated summaries (ISS and ISE), and other related clinical / regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications (NDAs) and Biologics License Applications (BLA) within agreed-upon timelines.
Education and Credentials
- Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment
- Bachelor's degree in life sciences or related disciplines; advance degree preferred (MD, PhD, PharmD, etc.)
- Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus.
Skills
Responsibilities
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Benefits
Contract - $60+ / hr.