Higher Scientific Officer in The Biologicals Team

**Details**:
**Reference number**:

- 421435

**Salary**:

- £38,795
- A Civil Service Pension with an employer contribution of 28.97%

GBP

**Job grade**:

- Higher Executive Officer
- Higher Scientific Officer

**Contract type**:

- Permanent

**Business area**:

- Biologicals Team

**Type of role**:

- Science

**Working pattern**:

- Flexible working, Full-time, Job share, Part-time

**Number of jobs available**:

- 3

**Contents**:

- Location
- About the job
- Benefits
- Things you need to know

**Location**:

- This role will be contractually based at the VMD, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS.
You will be expected to be in the office or working away from home for at least 60% of your time.
To meet the necessary security requirements for the VMD location, you must have been a resident in the UK for the past three years.
Organisation workplace includes the VMD office as well as time spent at other locations for meetings, conferences, and field-based activities. This is a non-contractual agreement which is consistent with common Civil Service expectations.

**About the job**:
**Job summary**:
**About the VMD**

You may not have heard of the Veterinary Medicines Directorate (VMD), but have you ever:

- eaten meat, eggs, fish or honey
- drunk milk
- owned a pet or animal
- taken antibiotics

If you said yes to any of the above, you are directly affected by what the VMD does.

The VMD is the regulatory and policy lead responsible for issues concerning the authorisation, use, and manufacture of veterinary medicines in the UK.

Our aim is to protect public health, animal health, and the environment, and promote animal welfare by assuring the safety, quality and effectiveness of veterinary medicines.

Find out more at: About us - Veterinary Medicines Directorate - GOV.UK

**About the**Job**

These exciting and interesting roles put you at the heart of the important work of the VMD’s Biologicals Section and the authorisation in the UK of biological/immunological veterinary products, including vaccines and novel therapy veterinary medicinal products.

The VMD is a leading regulator of veterinary medicines and has an active international profile. Your work will support the VMD’s aim to protect public health, animal health, and the environment and promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines.

**Job description**:
**You will be responsible for**:

- control of Biological’s Team Quality Management System (QMS) documentation.
- maintenance and update of databases and the reference documentation to support the work of the Biologicals Team.
- liaising with companies on final documentation for marketing authorisations.

**You will carry out**:

- batch release activities for immunological veterinary medicinal products.
- updates to databases to support 3Rs (Replacement, Reduction and Refinement) initiatives at National and International level.

**Your main duties will be**:

- prepare written assessment reports.
- communicate your assessments clearly to internal decision-making groups - to enable them to decide whether the data satisfy regulatory requirements and to decide on a course of action.
- work closely with assessors in the Biologicals Team to support their assessment work.
- undertake batch release activities for immunological veterinary medicinal products.
- monitor the Biologicals Team mailbox for the enquiries and requests of company meetings and provide support to Head of the team to comply with the VMD’s key performance indicators.
- liaise with companies on final documentation for marketing authorisations and document queries.
- liaise with the VMD’s Licensing Administration and IT teams to manage and update databases to reflect the needs of the organisation and to support the work of the Biologicals Team.
- control documents of the Biologicals Team Quality Management Systems (QMS), act as QMS representative for the Team and participate in internal and external audits and ensure team reference documents are up to date.
- participate in 3Rs (Replacement, Reduction and Refinement) initiatives at National and International level. You will maintain the animal use database with information on quality control (QC) tests of immunological veterinary medicinal products and conduct periodic data analysis to assess the trend of animal usage in QC tests for publication.
- maintain awareness of current developments and legislation affecting biological/immunological veterinary medicinal products.

**You will also**:

- comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and record management requirements.
- act corporately - meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.

**Person specification**:
**You must have experience of**:

- communicating scientific issues, in writing and face-to-face, with clarity
- proven ability to meet deadlines

**You must also have