Senior Medical Writer - Remote FSP, Clinical Docs

Syneos Health, Inc.; Portugal; Remote; EUR 72,000 - 156,000; Full time

Benefits offered by this job

Health benefits

401k

Bonuses

Job summary

Syneos Health is seeking a Senior Medical Writer with strong expertise in clinical document writing, including protocols, CSRs and IBs. This role focuses on delivering high-quality manuscripts and regulatory submissions while guiding a team of writers and collaborating with cross-functional teams.

The position offers remote work with potential EST/CST timezones and is open to Europe, LATAM, and North America.

Qualifications

• Clinical document writing experience including protocols, CSRs and IBs.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables across studies.
• Manages medical writing activities coordinating with multiple departments with minimal supervision.
• Leads the resolution of client comments.
• Coordinates quality and editorial reviews.
• Ensures source documentation is managed appropriately.
• Acts as peer reviewer for internal team to ensure content quality and formatting.
• Reviews statistical analysis plans and outputs for content and formatting.
• Interacts with clients and cross-functional teams to produce write-ups.
• Performs online clinical literature searches and copyright compliance.
• Identifies and proposes solutions, and provides training to staff.
• Mentors and leads less experienced medical writers on complex projects.
• Develops deep expertise on industry topics and regulatory guidelines.
• Monitors budget and communicates status to leadership.
• Completes administrative tasks within timeframes.
• Minimal travel may be required (<25%).

Skills

Medical writing

Regulatory standards

Job description

Syneos Health is seeking a Senior Medical Writer with strong expertise in clinical document writing, including protocols, CSRs and IBs. This role focuses on delivering high-quality manuscripts and regulatory submissions while guiding a team of writers and collaborating with cross-functional teams.

The position offers remote work with potential EST/CST timezones and is open to Europe, LATAM, and North America.