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First Name*

Last Name*

Email*

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Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Publishing & Submissions

Location: United Kingdom

An exciting opportunity has arisen for a Regulatory Submissions Publisher to create Regulatory Submission Dossiers for Clinical trials, marketing authorisation approval and or pharmaceutical products. This role is based in Kent, working remotely.

Job Responsibilities

Responsible for the building, publishing and associated tasks for assigned Regulatory submissions within agreed timelines.
Administrative activities such as tidying and reducing backlogs on the submission file shares and maintenance of publishing systems
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.
Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
Responsible for 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
Support global/local publishing teams when the need arises

Skills and Requirements

Proven technical aptitude
Quick learner with ability to multi-task
Ability to work with accuracy and attention to detail
Ability to work with autonomy and/or part of a team in a busy environment
Demonstrated ability to work in a highly regulated environment

To Apply

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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