Job Ref: 213089581

Date: 2021-01-27 18:04:50

Apply Now

An exciting new opportunity has arisen for a Part Time Data Compliance Associate in the medical compliance team within our client, a world leader in the pharma industry. This role is a temporary role for 12 months maternity cover, based in High Wycombe (albeit working from home during Covid lock down). The role is working 22.5 hours per week Monday to Friday, with a degree of flexibility on when the hours are worked during the day paying a pro rata salary of up to £15241 – £17550K equivalent to an hourly rate of £13-15 per hour depending on the level of skills and experience.

There is an increasing need for company activities that generate, collect, utilize or analyse human data collected from Health Care Professionals (HCPs), patients, consumers or caregivers. These activities are increasingly coming under more scrutiny to ensure they are compliant and conducted in an appropriate manner. The Medical Compliance function facilitates Activity Owners and Subject Matter Experts in ensuring the compliant execution of these activities, from concept to close out, and alignment with our local, regional and global processes.

The Purpose of this role is to:

· Provide administrative support for Research Related Activities (RRAs), local implementation of Pre-Approval Access Programs and local Compassionate Use activities and Investigator Initiated Studies (IIS).

· Support in the maintenance of the local and Global activity repositories and trackers for all activities for the UK and ROI.

· To support the local business to ensure it is always audit and inspection ready for RRAs.

Activities & Systems

Maintain Proposal Review Panel (PRP) meeting agenda and calendar invites to activity owners and subject matter experts (SMEs).
Arrange global assignment of RRA training to activity owners prior to PRP meeting.
Generate unique local identification number for activities coming to PRP and also Pre-Approval Access Programs, local Compassionate Use activities and IIS's.
Create activity folders for each activity.
Proactively maintain activity entries in the local and Global trackers and repositories and perform quality checks.
Notify Medical Compliance team of identified deviations.
Ensure all activities are closed out compliantly in the local and global repositories.

Medical Compliance

Handle incoming and outgoing electronic correspondence
Input into creation and review of Medical Compliance processes

Miscellaneous

Contributes to initiatives around lessons learnt and change management to ensure

efficiency gains.

Skills required.

Knowledge of general medical compliance requirements.

Experience in regulatory, health care compliance, quality or drug safety is an advantage but not a prerequisite.

Process focussed

Good organisation skills.

Good communication and collaboration skills.

IT skills, Microsoft Office applications

Apply Now