Principal Medical Writer
4 giorni fa
Principal 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 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-18808-Ljbffr
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Milan, Italia Altro 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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Technical writer
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Senior Principal Medical Writer
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Milan, Italia Altro A tempo pienoOverviewSenior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...
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Clinical Evaluation Medical Writer
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Milan, Italia Altro A tempo pienoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeThe Clinical Evaluation Medical Writer at Medtronic plays a pivotal role in the Clinical Job...
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Clinical Evaluation Medical Writer
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Milan, Italia Altro A tempo pienoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeThe Clinical Evaluation Medical Writer at Medtronic plays a pivotal role in the Clinical Job...
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Clinical Evaluation Medical Writer
2 settimane fa
Milan, Italia Medtronic A tempo pienoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Clinical Evaluation Medical Writer at Medtronic plays a pivotal role in the Clinical Job...
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Developing Medical Expert Women Healthcare
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Developing Medical Expert Women Healthcare
1 settimana fa
Milan, Italia Altro A tempo pienoSign in to set job alerts for “Medical Science Liaison” roles. Medical Science Liaison, Oncology, Italy, Israel, Turkey & Greece aT1D Field Readiness Associate Emilia Romagna Director, Field Medical Affairs (Rare Diseases) Associate Medical Evidence Advisor Lung Cancer (Maternity Leave) Senior Director, Medical Affairs, South Europe Regulatory Affairs...
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Senior Medical Writer
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Greater Milan Metropolitan Area, Italia Theron Solutions A tempo pieno 60.000 € - 120.000 € all'anoWe are looking for a talented professional with Medical Writing, Scientific writing skills, who can work on developing medical content and market access materials for the brands. This role will be working directly with one of our major pharmaceutical clients, based on-site at their office in Italy. The focus of the role will be to create medical and...
