Manager, Regulatory Records & Data Management

  • Salary: Up to £533.50 per day Ltd
  • REF Number: 00046842
  • Consultant: Jennifer Woolley
  • Contact: 01246 457725
  • Date Published: 21.10.2019
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

CK Group is recruiting for a Manager, Regulatory Records & Data Management to join a company in the healthcare industry at their site based in Stockley Park on a contract basis for 12 months and has a daily rate of £533.50.

The Company: As a global healthcare company, our client takes on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.

The Location: Stockley Park was the UKs first and most successful business park. Situated close to Heathrow Airport in West London, it is home to roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport a few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the park.

The Role: To ensure the data quality and consistent and effective use of registration data systems in order to support company Regulatory and Pharmacovigilance obligations, GMP-compliant product supply and business efficiency across the Pharmaceuticals Regulatory Function.

In this role, the position holder will be responsible for ensuring delivery of Regulatory Records & Data Management (RRDM) initiatives and projects and oversight of operational teams ensuring the timely execution of RRDM based requests.

Key Responsibilities:

  • Efficiently deliver on-time completion of all Regulatory Records & Data Management (RRDM) activities assigned in compliance with internal and external procedures/regulations.
  • Lead and motivate teams of Regulatory Records & Data Management associates, ensuring appropriate knowledge and competency is built and maintained to support existing and emerging workload.- Lead initiatives and projects to support evolving internal and external regulatory requirements impacting our Regulatory Information Management processes such as Registration Tracking, EVMPD, IDMP and CMC Technical Details.
  • Partner with GRPD Regulatory Systems, IT and external vendors to optimize delivery and use of regulatory data management systems and associated processes.
  • Collaborate with Regulatory Operations functions in Vaccines and Consumer Healthcare to maximize the alignment and efficiency of Registration Data Management across these Business Units.
  • Define system procedures, including reports, to support Business Processes effectively and manage change control procedures to ensure full impact assessment and robust implementation of change.
  • Identify cases of potential non-compliance with internal and external procedures and follow appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions and prevent future issues- Develop metrics, evaluate and improve performance of the RRDM team.

Your Background: To be considered for this role you should have previously experience within Regulatory Information Management or Regulatory Records in the Pharmaceutical industry. You should be comfortable representing your team at meetings, liasing with internal and external stakeholders and guiding others.

For more information or to apply for this position, please contact Jenni Woolley on 01438 768710 or email pharmacontracts@ckagroup.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 46842 in all correspondence. INDDIF

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