Senior Medical Writer

Senior Medical Writer - Sponsor dedicated - Remote role based in Europe Champions

Updated: Yesterday
Location: G
-Remote
Job :

Senior Medical Writer - Sponsor dedicated - Remote role based in Europe

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 brings the customer and the patient to the center of everything that 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.

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 accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees, across 110 countries, already know:

Why Syneos Health

• We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We continuously build the company we all want to work for and the customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to þess vert not founded individually.

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities for individual studies, coordinating with other departments with minimal supervision. Lead the resolution of client comments.
• Complete a variety of documents including clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; abstracts, posters,實student presentations for scientific meetings.
• Adhere to regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates, authorship requirements, and style guides, delivering projects on time and on budget.
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• Coordinate quality and editorial reviews. Ensure source documentation is managed appropriately. Lead team document reviews and perform reviews as needed.”
• Act as peer reviewer for the internal team to ensure scientific quality, clarity, consistency, and proper format.
• Review statistical analysis awọn plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Provide feedback to define statistical output and document needs.
• Interact and build working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate. Provide technical support, training, and consultation to department and other staff. Contribute to development of internal materials and presentations or process changes.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise in key industry topics and regulatory requirements that affect medical writing.
• Be PREFER THE BUDGET SPECIFICATION for assigned projectsाध, work within budgeted hours, and communicate status and changes to leadership.
• Complete Coverage administrative tasks within specified time frames.
• Performs other work‑related duties as assigned.
• Minimal travel may be required…