Lead Document Specialist

Janssen Research and Development is recruiting for a Lead Document Specialist, located in Titusville, NJ or Spring House, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research and Development is part of the Janssen Pharmaceutical Companies.

The Lead Document Specialist serves as the single point of contact for the authoring community, and is the subject matter expert to delivering submission-ready documents or other types of specialist support for assigned areas of responsibility. This individual collaborates closely with the authoring community and members of their team to ensure there is an agreed support model and process documentation. The Lead Document Specialist liaises with subject matter experts across the enterprise to ensure upstream and downstream process optimization. They are responsible for leading document deliverables for assigned areas, which involves working with the authoring community to determine timelines (ie, dossier or project planning) and ensuring resource availability. This person oversees the work request system for new requests and assigns requests to internal or external resources. The Lead Document Specialist will assist with external vendor alliance management activities by monitoring the quality of results and contributing to vendor work orders and will also be responsible for participating in initiatives, as applicable.

Key Responsibilities:

• Primarily supports clinical authoring templates (advanced Word and content/topic-controlled) which includes: creating/formatting new templates and updating template content with input from content owners; liaising between business areas, project management, and external vendor to ensure template updates are completed as expected or to troubleshoot technical issues; training new template users.
• Takes a leadership role for the monitoring and efficiency of the document-level support processes and initiates changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
• Coordinates operational aspects of document-level support activities, such as, collaborating closely with authoring community to plan for upcoming support needs, connecting with resources to ensure availability to meet support needs, and resolving any resource gaps.
• In collaboration with the document authoring teams, compile, integrate and publish documents with word processing, electronic publishing, and document management systems.
• Applies appropriate submission standards, requirements, processes, and policies to align with applicable health agency requirements.
• Cultivates ongoing effective relationships across global regulatory affairs; as well as cross-functionally. Maintains open communications with key partners to ensure priority discord, resource issues, and deviations from the plan are identified and resolved.
• Assists with training of new processes or software, as applicable.