Regulatory Professionals are collaborating with a global, Japanese pharmaceutical company that focus on Neurology, Oncology, and infectious disease treatments. Our client is looking for an experienced Publishing Manager to join their team based in Hertfordshire. You will be responsible for planning, forecasting, and scheduling report publishing projects in accordance with company timelines.
Other duties will include:
Oversee global publishing and submission processes for domestic and international regulatory bodies.
Manage the process from inception to approval with a focus on delivery with excellence while maintaining quality and compliance.
Work to create and maintain publishing timelines that can be referenced by team members for all projects.
Manage vendor relationships, as needed, related to regulatory operations activities.
Represent Report Publishing on assigned project teams to support product submissions and scheduling to ensure efficient communication and coordination for timely regulatory submissions.
Help develop and implement the system and process improvements to support greater efficiency in publishing that enhance submission standards, working practices, and documentation quality controls.
Conduct cross-functional training on publishing standards and procedures.
Manage, support, and develop Regulatory Operation and secure resources to support the company's goals and objectives
Publishing & Submissions:
Experience with paper submissions and conversion to electronic formats
Expertise in electronic publishing and submissions of guidance-compliant eCTD structure
Strong knowledge of US and other major global (ICH, EU, Asia) regulatory requirements and operations experience
Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins, electronic document management systems, eCTD publishing tools, eCTD validation, and viewing tools.
Skills and aptitude required:
Strong computer skills, project management skills, and strong attention to detail, and the ability to manage multiple tasks
Strong communication skills (both written and oral)
Strong interpersonal skills with an ability to communicate across different levels
Diplomacy and rationale in difficult situations
Ability to handle many tasks and setting shifting and competing priorities
Creative and analytical in approach