- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, ... high-quality clinical regulatory documents while adhering to regulatory guidelines....Qualifications4 or More Years of experience as a medical writer with a graduate degree (Doctorate preferred) in a… more
- Vistra (Bear Valley, CA)
- …currently available and apply online. **Job Summary** The Senior Nuclear Operations Regulatory Exam Writer /Instructor develops and administers Regulatory ... Criteria for assigned programs, including interfacing with INPO and Nuclear Regulatory Commission (NRC) as required. + Interacting professionally with other station… more
- Cordis (Irvine, CA)
- …people who keep saving lives. MedAlliance (Cordis) are currently seeking a **Technical Writer ** to join our Regulatory Affairs department, focusing on the ... for Use (IFUs), to support our product compliance and regulatory submissions. As a Technical Writer within the Regulatory Affairs department, you will… more
- Entergy (The Woodlands, TX)
- …**Legal Entity:** Entergy Services, LLC **BRIEF POSITION DESCRIPTION** The Security & Regulatory Technical Writer will be responsible for documenting the ... Electric Reliability Corporation (NERC), Critical Infrastructure Protection (CIP), Nuclear Regulatory Commission (NRC), Nuclear Cyber (10 CFR 73.54), Sarbanes Oxley… more
- Actalent (Rockville, MD)
- …preferred. Additional Skills & Qualifications + 4-5 years of experience as a Medical Writer with regulatory submissions and CSR development background . + 1-2 ... Job Title: Senior Medical Writer Job Description Responsibilities + Independently write and...(CSRs), including Tables, Figures, Listings (TFL), and early phase regulatory submissions. + Ability to independently lead the development… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …Social Science Support - Positions may include: Biostatistician; Clinical Data Manager/ Regulatory Writer ; Quality Assurance Officer; Regulatory Scientist; ... Regulatory , Clinical, and Technical Clinical Trial support Location...Technical Writer ; Program Manager; Biomedical Science Writer ; Principal Investigator. + Medical Services - a .… more
- Humera (Maple Grove, MN)
- …Writer II, for our client based in Maple Grove, MN The Sr. Medical Writer on the Regulatory Clinical Evaluation team provides technical and strategic writing ... Medical Writer II | Maple Grove, MN Medical ...including clinical evaluation plan, PMS and PMCF plans, SSCPs, regulatory responses and other items + Evaluates and summarizes… more
- NextEra Energy (Jupiter, FL)
- …our world-class team today! **Position Specific Description** The Nuclear Operations Regulatory Exam Writer /Instructor develops and administers Regulatory ... **Nuclear Training Operations Instructor Sr Fleet ( Regulatory Exam Author)** **Date:** Jan 8, 2025 **Location(s):** Jupiter, FL, US, 33478 **Company:** NextEra… more
- Holtec International (Covert, MI)
- …and historic undertaking for the industry and the nation! JOB SUMMARY The Exam Writer develops and administers Regulatory Exams in accordance with NUREG 1021, ... Exam Writer Holtec Decommissioning International (HDI) is currently seeking...for assigned programs, including interfacing with INPO and Nuclear Regulatory Commission (NRC) as required. + Interacting professionally with… more
- BeiGene (San Mateo, CA)
- …Education/Experience Required: + 7+ years of relevant industry experience as a regulatory medical writer with a BA/BS degree. All qualified applicants ... Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory … more
- Abbott (Santa Clara, CA)
- …fingersticks. **The Opportunity** The function of a **Senior Medical Writer /Project Manager** supporting our Vascular Clinical Evaluation Products combines ... device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices...2.7/1 Rev 4) and EU Regulation 2017/745. The CER Writer /PM is recognized as a subject matter expert for… more
- University of Miami (Miami, FL)
- …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 data and translates complex scientific concepts,...of clinical trials including protocol and ICF development, institutional regulatory submissions (Protocol Review and Monitoring Committee [PRMC] and… more
- Baptist Memorial (Memphis, TN)
- Summary The Scientific Writer will write, edit, and review manuscripts, grant proposals, research reports, and other scientific communications. Responsibilities ... developing project synopses, outlines, and complete scientific works. The Scientific Writer will ensure effective communication of analytic findings and perform… more
- Novo Nordisk (Lexington, MA)
- …Are you ready to make a difference? The Position The Senior Medical Writer works closely with cross-functional project teams to manage preparation of the written ... deliverables that support the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a… more
- J&J Family of Companies (Spring House, PA)
- …their potential. At Johnson & Johnson, we all belong. The Nonclinical Submissions Writer will prepare and review regulatory submission documents that summarize ... Johnson & Johnson is recruiting for Nonclinical Submissions Writer , Preclinical Sciences and Translational Safety to join our team located at our Spring House, PA… more
- System One (Horsham, PA)
- Title: Medical Writer - Scientific Communications Location: Remote (or local to Horsham, PA) Salary: $160,000-$170,000 - FTE INSTAFF Benefits Group: Scientific ... Communications Leading Pharmaceutical Company located in NJ is hiring a Medical Writer - Scientific Communications w/ 5+ years industry experience. If you want to be… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …group where the writer will receive hands-on writing clinical documents for regulatory submissions. In this role, the Medical Writer will gain experience: + ... Regeneron is seeking a Medical Writer who is highly motivated to learn the...learn the skills needed to write a variety of regulatory documents and publications to support Regeneron's drug development… more
- Koniag Government Services (Washington, DC)
- …Professional Services, LLC** a Koniag Government Services company, is seeking a Writer Editor 2 to support **KPS** and our government customer in Washington, ... ensuring clear and effective messaging that aligns with organizational objectives. The Writer /Editor will perform a wide variety of writing and editing services… more
- Grifols Shared Services North America, Inc (Columbus, OH)
- …such as final Clinical Study Reports, abstracts, white paper reviews and regulatory agency submission documents on a given product or medical question across ... protocol shells, updating the investigator brochures, annual safety reports and for regulatory documents such as sections of Biological License Applications to FDA… more
- System One (San Rafael, CA)
- Job Order #: 329444 Title of Position: Medical Writer Location: San Rafael, CA Type: Contract Pay Rate: $50-$54/hr. W2 ONLY (NO STEM OPT CANDIDATES) Hybrid (1-2 days ... in office to align with company policy). The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in… more
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