Manager, FSP Medical Writing - Remote

Overview

Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.

In Short

• Manage a team of internal writers serving as Functional Service Providers (FSPs).
• Coordinate resources and develop work plans that align with internal and external goals.
• Oversee quality performance of FSPs ensuring compliance with regulations.
• Liaise with Executive Leadership to report on staff utilization and KPIs.
• Support Medical Writing and Business Development in work orders and budgets.
• Provide guidance for document development for regulatory writing deliverables.
• Produce clinical protocols, study reports, and other regulatory documents.
• Collaborate cross-functionally with client teams in various departments.
• Ensure all FSPs meet qualifications and training requirements.
• Work under minimal supervision while maintaining exceptional communication.

Requirements

• Undergraduate degree in a scientific or health-related field.
• Minimum 5 years of clinical research/drug development experience.
• Experience managing diverse teams preferred.
• Exceptional communication and interpersonal skills.
• Excellent organizational and project management skills.
• Experience with regulatory documents and drug development processes.
• Proficient with Microsoft Office Suite.
• Working knowledge of GCP, 21 CFR, CTD, ICH guidelines/regulations.

Benefits

• Equal employment opportunities for all employees.
• Prohibition of discrimination and harassment in the workplace.
• Supportive work environment focused on collaboration and growth.