Medical Writer 1 (Syneos)

Roles and Responsibilities

JOB RESPONSIBILITIES

• Works within Veeva RIM, adapted to client requirements, to support accurate and compliant document filing.

• Performs eTMF filing activities, with an understanding of TMP filing, including key medical and regulatory components, while adhering to GxP guidelines (well-read and good understanding of GxP guidelines)

  • Manages document handling activities within Veeva, including downloading records from internal systems and uploading them into Veeva with accurate classification and storage

  • Ensures that all documents meet required quality and integrity standards before filing

  • Ensures tracking project documents and supports efficient access and keeps project data up to date

  • Maintains delivery timelines and ensures projects meet deadlines and milestones effectively

  • Categorizes documents systematically to streamline retrieval and organization processes

• Ensures correct naming conventions, validating metadata, and placing documents in their appropriate locations within the Veeva system

• Understands the filing scope that includes but not limited to Early Access Programs and individual requests, External Research Projects, and Observational and Non-Interventional Studies

• Contributes to the creation and refinement of new processes, workflows, and SOPs, and adapt effectively to evolving operational requirements.

• Collaborates with client stakeholders and demonstrate a proactive, learning-oriented approach supported by strong communication skills, even without extensive project or stakeholder management experience.

• Showcases strong attention to detail and adherence to established filing guidelines to maintain compliance and system integrity.

• Demonstrates understanding of digital archiving practices and ensures electronic records are securely, systematically, and permanently preserved.

• Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.

• Participates in internal and client-facing meetings, as required, to liaise with client stakeholders and

facilitate resolution of comments while ensuring alignment with stakeholder expectations and adherence to agreed timelines and submission deadlines.

• Monitors timelines for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.