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Job Details

Associate Global Submission Manager

Company: PRA Health Sciences
Location: Office based in central London, or home based
Reference: FC 2018 51169
Closing Date: 21 Mar 19
Type: Full Time
Salary (£): Competitive
Benefits: Pension, private medical insurance, flexible hours

Job Summary:

As an Associate Global Submission Manager, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. For this role, we are open to considering junior yet enthusiastic candidates who are keen to embark on a career in regulatory operations, or individuals with some previous experience.

Requirements:

Position overview:

The Associate Global Submission Manager collaborates with regional and global cross-functional teams to plan, prepare and deliver compliant regulatory submissions, providing support to ensure all business deliverables are met.

Working on this exclusive client partnership, the Associate Global Submission Manager will compile and execute submission strategy plans for new marketing authorisations as well as submission strategies for the maintenance of existing drug licenses.

Working from pre-submission stage onwards, the role of an Associate Global Submission Manager is varied. Key tasks will include:

  • Monitor, interpret and validate evolving agency submission standards and policies and assess the potential impact to business processes
  • Contribute to solutions to regulatory submissions issues by identifying potential risks and inputting mitigation plans
  • Lead the cross-functional submissions team, including planning and co-hosting kick-off meetings and preparing materials to facilitate team discussions, timeline mapping and strategy formulation
  • Creation of risk, escalation and communication plans
  • Maintain submission schedules in MS Project
  • Create and maintain submission forecasts for resource planning
  • Champion embedded processes and best practices within global and local teams in the creation of submission-ready documents, manage dates for document handover (in collaboration with the publishing group)
  • Acquire an understanding of the internal and external interdependencies among submission activities that could impact the submission schedule and ensure timeline goals are achieved, whilst also maintaining high quality

As an Associate, you will benefit from the support of the more experienced team of managers and also be encouraged to leverage the support of your functional manager to ensure a high level of quality and fulfilment of PRA’s core values of innovation and passion.

You are:

Detail-orientated, innovative and a strong communicator.

We believe it’s not just the words on your CV that matter – we are open to considering junior candidates who are keen to gain regulatory operations and project management experience, and individuals with previous relevant experience. Junior candidates should be commutable to central London, and home-based working is an option for experienced professionals.

To enable success in this position you will have:

  • A relevant educational background in a life-sciences discipline
  • Previous experience in submissions, regulatory operations or publishing. For junior candidates, this experience can be substituted for enthusiasm and genuine interest in regulatory operations.
  • Strong project management skills
  • Fluency in English

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

Apply for this job: Associate Global Submission Manager

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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