Senior Medical Writer – Late Phase Inflammation

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Leads the clear and accurate completion of medical writing deliverables • Manages medical writing activities associated with individual studies • Completes a variety of documents that may include clinical study protocols, reports, narratives, and presentations • Adheres to established regulatory standards and coordinates quality reviews • Acts as peer reviewer for internal team and identifies resolutions for issues • Provides technical support and training to staff

🎯 Requirements

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately • Manages medical writing activities associated with individual studies, 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; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines • Coordinates quality and editorial reviews • Ensures source documentation is managed appropriately • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format • Identifies and proposes solutions to resolve issues, escalating as appropriate • Provides technical support, training, and consultation to department and other company staff

🏖️ Benefits

• 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 building an inclusive culture – where you can authentically be yourself