- University of Miami (Miami, FL)
- …SCCC - Protocol Development Office (PDO) has an exciting opportunity for a Full Time Scientific Writer (Medical Writer ) to work Remotely. CORE JOB SUMMARY ... The Scientific Writer analyzes scientific ...conformance to applicable submissions requirements 4. Reviews and ensures document language is scientifically/medically correct, responsive to the … more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Scientific Writer position is responsible for performing a variety of tasks including preparing laboratory and clinical studies and ... agency requirements. + Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills… more
- University of Miami (Miami, FL)
- …of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Scientific Writer to work at the UHealth Medical Campus. The Scientific ... clarity, consistency, and compliance with applicable submission requirements. + Reviews document language for scientific and medical accuracy; suggests… more
- MD Anderson Cancer Center (Houston, TX)
- …a submission-ready document . Writing for technical audiences Writes and edits scientific research proposals, grants, and reports at the direction of the research ... patient education/materials, IRB forms. Works collaboratively with research nurse manager and regulatory staff to develop or coordinate the development of the study… more
- Takeda Pharmaceuticals (Columbus, OH)
- …writing strategy for key clinical and regulatory documents and regulatory submissions; guides medical writing document preparation, including coordination of ... guidance on a wide range of issues related to document preparation, including US and international regulatory ...process, and standards). + As required, serves as lead writer for important clinical and regulatory documents… more
- AbbVie (Chicago, IL)
- …Principal Strategic Medical Writer is responsible for providing clinical and regulatory document support and advanced scientific writing expertise for ... multiple compounds or projects within a therapeutic area. Works with clinical and regulatory teams. Responsibilities: + Independently serves as a lead on a large… more
- Pfizer (Boston, MA)
- …clinical summaries for marketing applications, and responses to queries from regulatory authorities. + Understands the principles of scientific writing; ... **ROLE SUMMARY** + The Medical Writer (Senior Manager/Associate Director) creates documents pertaining to...relevant internal processes and standards as well as external regulatory guidance. + Manages all aspects of document… more
- Kelly Services (Oklahoma City, OK)
- **Tech** **nical** ** Writer (GMP)** **Batch Record Review & Deviation Investigation** **Location** : Hybrid/Oklahoma City, OK **Job Summary** : We are seeking an ... experienced Manufacturing Tech Writer with a strong background in GMP environments and...batch records, and other documentation to ensure compliance with regulatory standards. You will also serve as the point… more
- Philips (Baltimore, MD)
- **Senior Medical Writer - Sleep & Respiratory Care** The Senior Medical Writer will be responsible for authoring and maintaining clinical and post-market ... contribute to our author other technical documents that support Clinical, Regulatory , Risk Management, or Post-Market Surveillance efforts (eg, Clinical Evidence… more
- Kelly Services (Sunnyvale, CA)
- …Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, ... in Sunnyvale, CA (3 days/week in the office) **Position Title:** Technical Writer **Position Type:** One year contract **Pay rate:** $45-55/ hour. **Company:**… more
- Kelly Services (Sunnyvale, CA)
- …**Pay** : $50-$60/hr **12 month contract role** **Overview** : The Technical Writer is responsible for writing, editing, formatting, and managing the publication and ... for in vitro diagnostic Xpert tests and GeneXpert instrument systems. Document types include Instructions for Use, Quick Reference Instructions, User's Guides,… more
- AbbVie (Remote, OR)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description Summary The Senior Medical Writer is responsible for providing medical writing, ensuring successful ... and SOPs. Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application… more
- US Army Communications Electronics Command (Aberdeen Proving Ground, MD)
- …eXtensible Markup Language (XML), as well as low-level IT such as Portable Document Format (PDF) and word processing to edit and manage electronic documents. ... of your application. Additional information about transcripts is in this document . General Experience: Three years progressively responsible experience, 1 year of… more
- J&J Family of Companies (Columbus, OH)
- …Writing interdependencies between all major documents of electronic Common Technical Document (eCTD) is required. + Experience conducting Regulatory Medical ... Director, Regulatory Medical Writing (1 of 4) - 2406211847W... Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities as it… more
- Takeda Pharmaceuticals (Columbus, OH)
- …requirements and corporate policies, as well as work experience, to ensure regulatory compliance by assessing document requirements and identify information gaps ... management, with ability to prioritize, manage multiple programs within strict regulatory /compliance deadlines, and lead internal/external and scientific teams… more
- Takeda Pharmaceuticals (Columbus, OH)
- … submission documents. Collaborate with all Takeda regions to ensure a medical writing regulatory document strategy is created and executed upon for all products ... task forces (related to projects, process, and standards). As required, serves as lead writer for important regulatory response documents and key components of … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …managing strategic content strategies, overseeing an individual portfolio of scientific /technical annual reports, drafting proposals and other collateral as needed ... and pledges: + Annual reporting schedule and workflow for Donor Relations Science Writer /Proposal Writers to ensure timely delivery of reports to donors; + Editorial… more
- Pfizer (Pearl River, NY)
- …strategy. + Provides oversight to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and ... and specialized problems related to clinical research programs. + Applies technical/ scientific expertise to resolve problems regarding the clinical components of… more
- BeiGene (San Mateo, CA)
- …clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project ... INDs, MAAs, and NDAs is a plus + The technical/ scientific ability to critically analyze, synthesize, and present complex...+ 7+ years of relevant industry experience as a regulatory medical writer with a BA/BS degree.… more
- Pfizer (Pearl River, NY)
- …with the clinical program strategy. + Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and ... SUMMARY** + The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single… more