Principal Medical Writer / Sr Principal medical Writer- Sponsor-dedicated Updated: Yesterday Location: Remote, MI, Italy Job ID: 25113363-OTHLOC-3531-2DR Description Principal Medical Writer / Sr Principal medical Writer- Sponsor-dedicated Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.

Our Clinical

Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver- for one another, our customers, and, most importantly, for those in need. technical and therapeutic area training

- We are committed to building an inclusive culture- where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; annual reports; annual reports; plain language summaries; periodic safety update reports, clinical development plans; integrated summary reports
- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained. Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately. Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.



Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Mentors and leads less experienced medical writers on complex documents. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Communicates status and changes to medical writing leadership
- Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.

Qualifications At least 6 years of relevant experience in science, technical, or medical writing. Extensive experience working in the biopharmaceutical, device, or contract research organization industry required. Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices required.

Extensive experience writing relevant document types required. Extensive knowledge of English grammar and able to communicate clearly; strong familiarity with AMA Manual of Style. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Learn more about Syneos Health. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . Further, nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.

Summary Job DescriptionLeads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.



Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; annual reports; annual reports; plain language summaries; periodic safety update reports, clinical development plans; integrated summary reports

- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained. Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately. Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Mentors and leads less experienced medical writers on complex documents. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Communicates status and changes to medical writing leadership
- Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients' lives around the world.

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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients.

📌 Medical Writers (Bologna)
🏢 Syneos Health
📍 Bologna