Biological assessor in the biologicals section - united kingdom, addlestone, surrey

location

woodham lane, new haw, addlestone, surrey kt15 3ls

about the job s

summary

this exciting and interesting job put you at the heart of the important work of the vmd s biologicals section, principally in the following areas:

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 and overall benefit:risk balance.

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 of 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

job description

you will be responsible for the assessment of quality, safety and efficacy data and benefit:risk of applications for:

• new marketing authorisations for biological and immunological veterinary medicinal products

• variations to existing marketing authorisations

• animal test certificates to conduct clinical field trials

you will also provide expertise within the biological/immunological veterinary medicine areas, including:

• 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

• activities related to the international work of vmd

responsibilities

your main duties will be to:

• scientifically assess quality, safety and efficacy data for marketing authorisations, animal test certificates and variations 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 section 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

• contribute to wider vmd initiatives, such as training and development, publicity programmes, and international work programmes.

experience

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, nucleic acid vaccines, bacteriophage therapies 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.

it skills

you must be proficient in the use of microsoft office packages, particularly word, excel , powerpoint and outlook. you must use the internet effectively and have the aptitude to learn how to use the vmd s bespoke it systems.

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

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

• onsite gym

• access to a prayer room.

things you need to know security

successful candidates must pass a disclosure and barring security check.

successful candidates must meet the security requirements before they can be appointed. the level of security needed is counter-terrorist check ().

see our vetting charter ().

people working with government assets must complete basic personnel security standard () checks.

selection process details

this vacancy is using success profiles (), and will assess your behaviours, strengths and experience.

application process

as part of the application process, you will be asked to complete a cv and statement of suitability, and behaviour statements. the cv will ask for your job history, qualifications and past skills and experience. your statement of suitability should be no more than 750 words. you must provide a description of the skills, experience and attributes you would bring to this role, with particular relevance to the responsibilities and experience as listed.

sift

should a large number of applications be received, an initial sift may be conducted using the statement of suitability. candidates who pass the initial sift may be progressed to a full sift, or progressed straight to assessment/interview.

interview

if successful at application stage, you will be invited to interview where you will be assessed on behaviours, experience, and strengths.

applicants attending for interview may be required to complete a scenario-based practical - details will be notified to applicants who are shortlisted

sift and interview dates

the sift will be conducted week commencing 1st august 2022.

..... click apply for full job details

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