Senior eCTD Publisher Job - UK - Swindon - 12 months maternity cover

Job Title: Senior Regulatory Publisher


II. Basic Function:

The preparation, publishing, submission, maintenance, tracking and operational organization of any kind of paper and/or electronic submission for one or more regulatory projects and serving as regulatory publishing representative on project teams.

To work closely with business development resources to promote the service and generate new leads and opportunities.

III. Specific Activities, and Responsibilities:

o To lead and assist regulatory consultants in the preparation (assembly, publishing, printing and dispatching) of the regulatory dossier.
o Provide consultation, education and advice on the submission publishing process to internal consultants and external clients.
o Participate in regulatory project teams and interface with regulatory and clinical consultants to ensure timely submission of dossiers.
o Provide submission readiness assessments to submission project managers using system reports.
o Assist consultants with submission support through archiving submission related material and correspondence to and from Health Authorities.
o Ensure that submission standards are maintained and are readily available to the end users.
o To support the preparation and execution of IQ/OQ and PQ as required in support of software version updates.
o To maintain controlled documents in compliance with local and corporate policy and procedural requirements to include document management support for new Policies, SOPs and Forms, Change Control, Periodic Reviews and obsolete documents.
o To support continuous improvement of systems under Regulatory Publishing control to ensure system robustness, reliability and cost effectiveness and which meet the current and ongoing needs of the group and its clients.
o To ensure that you maintain a high level of current knowledge of eCTD and submission standards and other business systems and processes through personal development and training
o To provide a primary contact for consultants, clients and compliance groups with regards to eCTD, DMS/ Documentum and Compliance Wire applications
o To write clear concise SOP’s, reports and memos to a high technical standard as required.
o To make effective training presentations as required.
o To work closely with business development resources to promote the service and generate new leads and opportunities.

IV. Knowledge Requirements:

Education or Equivalent: (Minimum required to perform job)

• Degree qualified
• 2-3 years regulatory publishing experience using any eCTD system and DMS
• Evidence of ongoing IT skills training

V. Contact Information
Julie Cooper
Julie@mosaicrecruitment.co.uk