Principal Medical Writer
1 settimana fa
Principal Medical Writer – Submission Docs **********************) – Oncology – Remote BasedPrincipal Medical Writer – Submission Docs **********************) – Oncology – Remote Based atSyneos Health.Syneos Health is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model places the customer and the patient at the center of everything we do.We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.Job ResponsibilitiesDevelop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines and standards.Manage medical writing projects, developing timelines with study/project teams and communicating with cross-functional team members to maintain awareness of review cycles and expectations.Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes needed for regulatory documents.Review related documents associated with assigned projects (e.g., Protocols and Statistical Analysis Plans) as appropriate.Leverage eCTD submission experience.Responsible for writing and overseeing documents; does not mentor junior writers or manage external vendors.Additional Information: Tasks, duties, and responsibilities listed here are not exhaustive.The company may assign other tasks or responsibilities at its discretion.Equivalent experience, skills, and/or education will also be considered.The company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate, to assist employees or applicants to perform the essential functions of the job.SummaryThe Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally.Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements.Writes or provides direction and leadership to other writers to ensure timely delivery of high-quality documents.Oversees medical writing activities of multiple compounds and serves as lead writer for individual summary documents.Has a broad understanding of clinical research processes and global regulatory document standards.Mentors less experienced writers.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionMarketing, Public Relations, and Writing/Editing#J-*****-Ljbffr
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Remote Principal Medical Writer
3 settimane fa
milano, Italia Syneos Health, Inc. A tempo pienoA leading biopharmaceutical solutions company is looking for a Principal Medical Writer to develop regulatory documents for global submissions. This role entails managing writing projects, collaborating with cross-functional teams, and ensuring compliance with global guidelines. The ideal candidate will have experience in regulatory writing and a solid...
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Principal Medical Writer
3 settimane fa
milano, Italia Syneos Health A tempo pienoPrincipal Medical Writer – Submission Docs (2.5/2.7.2/2.7.3/2.7.4) – Oncology – Remote BasedPrincipal Medical Writer – Submission Docs (2.5/2.7.2/2.7.3/2.7.4) – Oncology – Remote Based at Syneos Health.Syneos Health is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate unique...
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Senior Medical Writer
18 ore fa
Milano, Lombardia, Italia The Bloc | Milan A tempo pienoSenior Medical Writer (Healthcare Advertising)The Bloc is the most diversified, fully independent health creative agency in the world. We provide comprehensive cross-channel services for audiences across the health spectrum, and partner with clients who are doing some of the most meaningful and exciting work in health today. And as part of an international...
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Medical Writer
2 settimane fa
milano, Italia Recordati A tempo pienoWith its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors...
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Senior Medical Writer, Oncology — Regulatory Submissions
1 settimana fa
Milano, Italia Syneos Health A tempo pienoA leading biopharmaceutical solutions organization is seeking a Principal Medical Writer to develop regulatory documents for global submissions.This mid-senior level role involves managing medical writing projects, providing strategic direction to cross-functional teams, and ensuring high-quality document delivery in compliance with regulatory...
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Medical Writer
3 settimane fa
Milano, Italia Recordati A tempo pienoWith its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors...
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Medical Writer
1 settimana fa
Milano, Italia Recordati A tempo pienoWith its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors...
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Medical Writer
2 giorni fa
Milano, Italia Agorà A tempo pienoSiamo alla ricerca diun **Medical Writer Freelance**, con esperienza nella scrittura medico-scientifica e nella revisione dei materiali promozionali in ambito pharma. la risorsa si occuperà su incarico di revisione e ottimizzazione di contenuti medici e scientifici, contribuendo alla comunicazione scientifica dell’organizzazione e assicurandone la...
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Senior Medical Writer — Regulatory Submissions Leader
3 settimane fa
Milano, Italia Recordati A tempo pienoA global pharmaceutical company is seeking a Medical Writer to support documentation throughout drug development. The successful candidate will prepare clinical study documents, perform quality control, and collaborate with cross-functional teams. Ideal applicants should have over 5 years of experience in medical writing, a relevant degree, and strong...
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Milano, Italia Medtronic A tempo pienoA leading medical technology company in Milan seeks a Clinical Evaluation Medical Writer to analyze clinical evidence supporting regulatory submissions. The role requires strong technical writing skills and proficiency in clinical research to ensure comprehensive literature reviews. Successful candidates will be well-versed in FDA regulations and able to...
