Grade 7 x 2 Biologicals Assessors in the Biologicals Team
These exciting and interesting jobs put you at the heart of the important work of the VMD’s Biologicals Team.
Job description
Scientific evaluation of data packages
Your primary role will be to authorise biological/immunological veterinary medicinal products in the UK. You will be responsible for the scientific evaluation of data packages against UK requirements for quality, safety and efficacy and making recommendations on the suitability of the product for use in animals.
We expect you to have a background that enables you to provide a specialist input into biological, quality and manufacturing aspects although it will be necessary to assess all areas of the dossier. You will work within a peer-reviewed environment and contribute to ensuring we make robust and transparent decisions on veterinary biologicals based on scientific evidence.
You will translate your background and experience of biological medicines to the competent and robust assessment of applications for marketing authorisations for biological veterinary medicinal products. Your work will play a major role in assuring the quality, safety and efficacy of animal medicines and will significantly contribute to the VMD meeting its published standards.
Authorisation of novel medicines
The field of biological medicines is a rapidly developing area and you will need to feel comfortable with the scientific and regulatory challenges that come with authorisation of novel medicines. You will play an influential role in shaping the regulation and scientific assessment of novel products in the veterinary medicines’ arena.
Review of scientific and regulatory guidelines
We will also expect you to maintain an awareness of scientific developments in the field of biological medicines and be proactive in the development and review of scientific and regulatory guidelines which support the quality, safety and efficacy requirements and act as an aid to the pharmaceutical industry and the development of medicines.
Our international profile
The VMD is a leading regulator of veterinary medicines and has an active international profile and you will be expected to contribute your expertise towards maintaining UK market appeal for veterinary medicines and aid future collaboration with other international regulators.
Your purpose
You will be responsible for the assessment of quality, safety and efficacy data for applications for:
- new marketing authorisations for biological and immunological veterinary medicinal products
- variations to existing marketing authorisations
- renewals of existing marketing authorisations, and
- animal test certificates to conduct clinical field trials.
You will also provide expertise within the biological/immunological veterinary medicine areas, including:
- activities related to the international work of VMD
- reviewing the scientific and regulatory guidelines and framework for biological/immunological veterinary medicinal products, including novel therapies and
- activities related to ensuring availability of biological/immunological veterinary medicinal products.
Your main duties
Your main duties will be to:
- scientifically assess quality, safety and efficacy data for marketing authorisations, animal test certificates, variations and renewals for biological/immunological veterinary medicinal products
- undertake a detailed evaluation of the data and, in liaison with other assessors, formulate a recommendation to accept or refuse the application, based on the benefits and risks you identify during the assessment
- prepare and peer review written assessment reports
- present assessment reports to UK and international scientific committees
- advise applicants on technical aspects of potential applications
- deal with enquiries and represent the Biologicals Team at meetings with internal and external stakeholders
- provide technical input relating to ensuring availability of biological/immunological veterinary medicinal products
- maintain awareness of current developments, legislation and guidance affecting biological/immunological veterinary medicines within National and International context
- contribute to development of scientific and regulatory industry guidance for biological/immunological veterinary medicinal products
- advise Defra and outside organisations, including logistics to ensure the availability of biological/immunological veterinary medicines
- collaborate with members of the Authorisations Division to achieve the Division’s overall objectives and
- contribute to wider VMD initiatives, such as training and development, publicity programmes, and international work programmes.
You must be proficient in the use of Microsoft Office packages, particularly Word, Excel and Outlook. You must use the internet effectively and have the aptitude to learn how to use the VMD’s bespoke IT systems.
Responsibilities
The following Experience criteria are essential to this post and will be tested at sift and interview:
You must have:
- practical experience in the development and/or manufacturing processes of biological/immunological medicinal products
- postgraduate experience which has given you a thorough working knowledge of biological medicinal product development, for example in the pharmaceutical industry in the development and/or manufacturing processes of biological/immunological products
- experience applying your analytical and problem–solving skills quickly to assimilate scientific and other information, identifying issues, drawing conclusions, and making recommendations preparing scientific reports relating to the evaluation of benefit/risk of these products
- experience communicating complex scientific issues, in writing and face-to-face, with clarity and conviction in the face of tough negotiation or challenge and
- experience prioritising continuous self-learning and development – identifying those areas that you need to develop to achieve your future objectives.
You must also have experience in or awareness of the following, or a demonstrable ability to get up to speed with them rapidly:
- the development and/or manufacturing of products such as cell therapies, monoclonal antibodies or other novel therapies
- current animal health and topical veterinary issues
- regulatory legislation and systems for biological/immunological medicinal veterinary products
- line management experience as, though the post has no current line management responsibility, this could change in the future.
Passport
You must have a valid passport
Qualifications
You must have a higher degree obtained by research in a relevant biological scientific discipline.
Behaviours
We'll assess you against these behaviours during the selection process:
- Working Together
- Making Effective Decisions
- Communicating and Influencing
- Delivering at Pace
Technical skills
We'll assess you against these technical skills during the selection process:
- IT Skills
Benefits
- Learning and development tailored to your role
- An environment with flexible working options
- A culture encouraging inclusion and diversity
- A Civil Service pension
- Free onsite parking
- Free eyesight test and a limited range of free glasses
- Onsite gym
- Access to a prayer room.