Expert Consultant - Toxicology

Expert Consultant - Toxicology

Labcorp is seeking an Expert Consultant - Toxicology to join our team in Tokyo or Remote within Japan.

Job Responsibilities:

• Act in Toxicology Expert Consultant Role, train, mentor and advise junior staff in area of expertise and/or regulatory matters.
• Provide customer advice on complex regulatory processes and requirements for lower and upper tier registration programmes with minimal support/ peer review.
• Advise on scientific issues in a regulatory context within area of expertise based on experience/ qualifications.
• Advise customers/ operations on regulatory and testing requirements for non-bespoke studies.
• Attend customer meetings as SME.
• Work on and review project work produced by other staff members to produce high quality work with on-time delivery for clients.
• Provide high level regulatory and scientific advice to clients, management and departmental regulatory staff, having gained a clear understanding of the client's regulatory strategy and objectives.
• Keep abreast of and communicate to the regulatory team new regulatory and scientific developments in order to help plan/focus the development for CP&C Regulatory Consultancy and testing businesses in area/s of expertise.
• JMAFF dossier preparation and Toxicology and/or Metabolism study sections expertise including Data Gap Analysis.
• Prepare study summaries via study reports within the section and MOA studies, evaluate literature. Preparation into required format(s) (OECD, Shoroku, etc...).
• Peer review documents prepared by other staff members to ensure they are accurate, and scientifically sound, meeting the requirements of the client and the JMAFF.
• Interpretation of results for C&L and RA of standard information requirements and selection of key studies for overall endpoint summaries.
• Scope out work required and prepare a proposal including cost build activities with the aid of planning and business staff.
• Provide mentoring support to colleagues, provide training in specific skills area - to Consultancy group, BD team, and wider CP&C community.
• Train new starter in day-to-day regulatory activities and departmental procedures.
• Introduce mentees to SME through a series of one-to-one training modules and supervise application of skill on project tasks.
• Continue to develop and build a profile of competency in Toxicology (SME) - provide training to groups or present at a small platform conference and contribute to establishing new processes to implement new requirements.
• Participate in task forces or industry groups/ associations, develop relationships and represent Labcorp.
• Communicate effectively and with high level of understanding of regulatory requirements to seek clarification from authorities
• Deal with post submission advice on behalf of customer.
• Be responsible for own performance; includes timely and accurate recording of hours worked, attainment of billability targets, sourcing work opportunities with team members, proactive management of objectives and professional development plus any other set performance indicators (5%).
• Responsible for pro-actively suggesting process improvements to systems, processes and infrastructure within CP&C Regulatory, to ensure effective and efficient performance (5%).

• 10 or more years of experience in toxicology within the regulatory testing or consultancy sectors.

• 3 or more months of significant demonstrable experience in technical understanding of toxicology, preferably on crop protection and chemical (CPC) studies.
• 3 or more months of strong industry profile with established relationships with regulatory authorities and CP&C customers, particularly in Japan and with JMAFF.
• Fluent in English and Japanese.

• Good communication skills with the ability to lead and engage with other project team members.
• The Expert Consultant is required to work 37.5 hours per week. On occasions flexibility over hours is required to accommodate travel (including department and client meetings and training/conferences) and the meeting of work deadlines.
• Role is primarily office-based (remote working), along with travel for customer and regulatory authority meetings and conferences.