Study Licensee

Job Overview

Applications are invited for the position of Study Licensee to provide maternity cover. The job is based within the Clinical Section of Research & Development Division and reporting to the Clinical Study Manager.

The successful candidate will participate in conducting in vivo phase of studies and will be responsible for generating and compiling data related to both regulatory and non-regulatory studies. All work will be carried out in an organised and timely manner, adhering to regulatory requirements (FDA/EMA/MHRA), and following the principles of GLP, GCP, and established SOPs.

Main Activities/Tasks
Responsible for overseeing the in vivo phase and acting as Licensee for a range of studies.
Conducting biochemistry and haematology analyses.
Ensuring all study activities are conducted in accordance with the study protocol and current SOPs and in accordance with Good Laboratory Practice (GLP).
Ensuring accurate documentation of all study aspects.
Generate, compile and review study documentation ensuring completeness and accuracy.
Reviewing study protocols to ensure regulatory compliance.
Writing and reviewing SOPs.

Essential Criteria:
Demonstrate flexibility and be available to work occasionally outside of regular working hours.
Previous experience in animal handling, husbandry, and care.
Possession of a valid Personal Licence or ability to obtain one.
Strong attention to details and ability to follow protocols precisely.
Capable of prioritising tasks and managing time efficiently.
Effective communication skills.
Ability to report findings accurately.
Be assertive, yet tactful.
Hold a full UK driving licence.

Desirable Criteria:
Qualification in animal science, biology, or veterinary would be advantageous.
Previous experience as a Study Licensee.
Previous experience in conducting biochemistry and haematology analysis.
Ability to perform validation and maintenance of laboratory equipment.
Have experience working in a GLP, GCP or GMP environment.
Understanding of relevant regulatory guidelines.

Duration: Full Time, Temporary maternity cover

Location: Newry

Additional Information:
Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
We regret that applications received after the closing date and time will not be accepted.
We are unable to sponsor or take over sponsorship of a Visa at this time.

Benefits:
Free Life Assurance
Company Pension - salary sacrifice scheme
Healthcare cash plan
32 days annual leave
Wedding Leave
Company Sick Pay
Company Maternity / Paternity
Paid bereavement leave
Cycle to Work Scheme
Tech Purchase Scheme
Employee Savings scheme
Employee well-being initiatives
Employee Assistance Programme
On-site free parking
Subsidised Canteen Facilities
Employee Perks scheme
Employee Recognition scheme
Career development opportunities