Managing Scientist - Efficacy

Our Opportunity

We are currently seeking an Efficacy Specialist with experience at a management level to operate within our Practice in our Nottingham (UK), Edinburgh (UK), Harrogate (UK), London (UK), Dublin (Ireland), Basel (Switzerland) or Mannheim (Germany) offices;

homeworking may also be considered. In this role you will work as part of a team to primarily prepare regulatory dossiers with respect to efficacy for plant protection products (including biopesticides).

You will be responsible for

Providing strategic advice and guidance to clients on EU and national efficacy data requirements, including the type and amount of efficacy data required to fulfil these requirements.

covering new active substances and product submissions, mutual recognition applications and re-registrations

• Acting as a liaison point between our clients and the EU regulatory authorities
• Writing Biological Assessment Dossiers and concise evaluation documents, supporting product authorisations, to EU / UK requirements, using SANCO / 10055 / 2013 Rev.

4format (including the provision of expert justifications in the absence of data)

• Writing efficacy sections of new active substance dossiers in OECD and IUCLID formats
• Writing Comparative Assessment dossiers, to national requirements, for plant protection products containing active substances, which are candidates for substitution
• Writing efficacy sections of Emergency Authorisation submissions for client’s plant protection products
• Undertaking Data Gap Analyses of client's existing efficacy data sets, providing guidance as to the type and amount of efficacy data required to meet current data requirements
• Designing efficacy study plans and providing expert comments on client's existing efficacy study plans
• Providing strategic guidance on the placing of efficacy tests within the EU / UK, which best fit the client’s needs
• Undertaking efficacy study monitoring and reviews of efficacy trial reports, on behalf of the client
• Maintaining technical expertise through attendance of relevant training courses, conferences workshops and meetings, and maintaining membership of professional bodies, as appropriate
• Managing efficacy projects and co-ordinating efficacy projects for clients
• Providing expert efficacy guidance to colleagues working within the other regulatory specialisms

You will have the following skills and qualifications

• A minimum of a . degree or equivalent, in the biological sciences or an agriculture related subject
• Strong and proven regulatory understanding with respect to efficacy data requirements for plant protection products
• An agronomic background, possibly gained from conducting efficacy field trials or managing other agronomic testing of plant protection products
• Experience in the preparation of Biological Assessment Dossiers for efficacy
• Some knowledge of biological pesticides would be advantageous but not essential
• Be a strong team-worker, with excellent project management skills, is motivated and assertive, demonstrates good judgement and is capable of sound decision-making
• Line management or team management experience would be advantageous
• Knowledge of any EU local (country-specific) regulations for efficacy would be advantageous
Il y a plus de 30 jours