ProClinical is advertising a vacancy for a Submissions Publisher position with one of the most prestigious pharmaceutical organisations in the world. The company specialises in developing and procuring medicines and vaccines for a wide range of therapeutic areas, including oncology, cardiology, and immunology. Based in the company's UK office, this position offers an exciting opportunity to work with a company that has been established for over 100 years and is a major supplier to the NHS.
The Submissions Publisher will work within a team to create Regulatory Agency Submission Packages (Dossier) using a number of build and publishing tools. The Dossiers are compiled in paper and/or electronic format with documentation received from Hub Submission Managers and submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorisation approval for pharmaceutical products.
- 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, through the use of 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 submission 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 and assigning to resources available within India or Sandwich.
- Supporting global/local teams publishing teams when the need arises.
- Adhering to P 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 various publishing tools such as ISI Publisher and proven knowledge of eCTD formats.
- Demonstrable 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 +44 203 854 2621 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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