Regulatory Affairs Business Project Manager

  • Salary: Up to £60 per hour
  • REF Number: 00046700
  • Consultant: Stephen Lord
  • Contact: DD: 01246 457738
  • Date Published: 03.10.2019
  • Sector: Non-Specific
  • Location: Home Counties
  • Discipline: Regulatory Affairs

Steve Lord at CK Clinical is recruiting for a Regulatory Affairs Business Project Manager to join a pharmaceutical company at their site based in Slough on a contract basis for a 12 month contract.

The Company: Our client is a multinational patient-focus biopharmaceutical company that focus on severe diseases.

The Location: The role is based at our client's site in Slough which is easily commutable from London and the surrounding areas.

The main purpose of the role will be to:

  • Provide project management expertise to a program of work designed to enhance processes, regulatory data, and user engagement whilst at the same time implementing a replacement Registration Information System.
  • As an experienced business project/program manager you will be able to work at a variety of different levels, from day to day project management duties to stakeholder management and orchestration of the program objectives.

Further responsibilities will include:

  • Day to day project management activities including management of issues and risks register, alignment of delivery and scheduling in conjunction with the IT project manager.
  • Coordination of stakeholder groups including core team and extended core team aimed at realizing maximum value from the project.
  • Reporting of status and highlighting milestones achieved and potential risks and known issues along with mitigation plans.
  • Developing, delivering and managing communication plans.
  • Working with the data migration manager and other stakeholders to establish a migration plan and monitor progress to ensure alignment with the broader program.
  • Planning and executing the business deliverables for GxP validation, understanding and facilitating process workshops and ensuring that the agreed process is captured in the associated documentation.
  • Ensuring that tailored training is delivered according to agreed timelines.
  • Own and manage the User Requirements Document and validate with key stakeholders, resolve conflicting requirement needs.
  • Working with key stakeholder to validate assumptions and refine user requirements.
  • Ensure that a business continuity plan is in place and that any existing transversal reporting is sustained at the point of go-live.
  • Incorporating additional process and data touchpoints, including alignment with external reporting environments.

Your Background:

  • 3+ years of experience in the pharmaceutical industry, with specific experience related to the processing of regulatory information management.
  • Minimum of 4 years of experience in project management preferably in the life science industry.
  • Demonstrable ability to bring complex projects through to completion.
  • Experience in preparation and delivery of training materials.
  • Extensive knowledge of registration tracking technologies, document best practices related to system usage, archiving, and tracking.

For more information or to apply for this position, please contact Steve Lord on 01246 457 738 or email slord@ckclinical.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46700 in all correspondence.

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