An internationally renowned pharmaceutical organisation is seeking to hire a Submissions Publisher for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
- Overseeing building, publishing, archiving activities, and associated tasks for assigned Regulatory submissions within agreed timelines.
- Adhering to quality control procedures and standards related to submission publishing.
- Adhering to the appropriate use of document management systems, publishing, and validation tools, using working practices and quality control steps to ensure Regulatory compliance.
- Supporting other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
- Overseeing key projects within a specific region to implement and train on any external agency updates for procedures or requirements.
- Leading major submissions.
- Coordinating the allocation of all publishing activities around the global publishing hubs to meet agreed deadlines, whilst tracking and monitoring all issues.
- Liaising with Global Submission Managers, Hub Submission Managers, and contributing lines to discuss and agree expectations and publishing timelines.
- Monitoring local mailbox for any urgent publishing requests.
- Supporting global/local publishing teams when the need arises.
- Adhering to compliance standards.
Skills and Requirements:
- Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards.
- Functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Proven technical aptitude.
- Experience of using publishing tools such as Liquent InSight and proven knowledge of eCTD formats.
- Demonstration of experience working in a customer service environment.
- multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Numhom Sudsok at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.