Principal Medical Writer
7 giorni fa
Principal Medical Writer – Submission Docs **********************) – Oncology – Remote BasedPrincipal Medical Writer – Submission Docs **********************) – Oncology – Remote Based at Syneos 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
2 giorni 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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Remote Principal Medical Writer
24 ore fa
Via 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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Medical Writer
5 giorni fa
Milano, Lombardia, Italia Recordati A tempo pienoJob Purpose We are looking for a Medical Writer that supports the company across the full life cycle of drug development, interacting with project teams to support the creation and development of clinical study documentation as well as other dossier related documentation. As medical writer, the role is required to support the medical writing team and to...
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Principal Medical Writer
1 settimana 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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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 Based Principal 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...
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Medical Writer
21 ore 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
5 giorni fa
Milano, Lombardia, Italia Recordati A tempo pieno*With 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
3 giorni 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
3 settimane 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 standards....
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Medical Writer
24 ore fa
Via 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...
