Medical Writer I – Junior Project Specialist

This is a fully remote position, open to applicants in India.

📋 Description

• Assist in the precise and compliant filing of documents within Veeva RIM.

• Execute eTMF filing tasks and oversee document handling procedures.

• Validate that documents meet quality standards prior to filing.

• Work collaboratively with stakeholders while adhering to project deadlines.

⛳️ Requirements

• Operate within Veeva RIM, tailored to client specifications, to facilitate accurate and compliant document filing.

• Conduct eTMF filing tasks, possessing knowledge of TMP filing, including essential medical and regulatory aspects, while complying with GxP guidelines (thoroughly knowledgeable and well-versed in GxP guidelines).

• Manage document handling processes within Veeva, such as downloading records from internal systems and uploading them into Veeva with proper classification and storage.

• Ensure all documents fulfill necessary quality and integrity standards before filing.

• Track project documents to support efficient access and maintain up-to-date project data.

• Uphold delivery timelines, ensuring that projects achieve deadlines and milestones effectively.

• Systematically categorize documents to enhance retrieval and organizational processes.

• Maintain accurate naming conventions, validate metadata, and position documents correctly within the Veeva system.

• Understand the scope of filing, which includes but is not limited to Early Access Programs, individual requests, External Research Projects, and Observational and Non-Interventional Studies.

• Contribute to the development and improvement of new processes, workflows, and SOPs, adapting effectively to changing operational needs.

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

• Display exceptional attention to detail and adherence to established filing guidelines to ensure compliance and system integrity.

• Exhibit knowledge of digital archiving practices, ensuring that electronic records are securely, systematically, and permanently preserved.

• Stay informed about FDA, EU, and other pertinent guidelines and industry standards to ensure documents meet or exceed sponsor and regulatory requirements and guidance.

• Engage in internal and client-facing meetings, as necessary, to communicate with client stakeholders and facilitate the resolution of comments while ensuring alignment with stakeholder expectations and adherence to agreed timelines and submission deadlines.

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

🏝️ Benefits

• We are dedicated to fostering the development of our employees through career advancement opportunities, supportive and engaged management, specialized training in technical and therapeutic areas, peer recognition, and a comprehensive rewards program.

• We are committed to creating an inclusive culture – where you can be your authentic self. Central to this mission is our purpose – Driven to Deliver – which embodies the passion of our colleagues to show up each day and craft solutions that can significantly impact someone's life.

• We are continuously striving to build the organization we all want to work for and that our customers want to partner with.