Job Description

A. Responsibilities/Duties

The Expert Consultant is responsible for providing high level regulatory and scientific advice to customers of CP&C Regulatory and/or testing services in their key area/s of expertise, particularly Japan and APAC customers.

The Expert Consultant will be responsible for performing consultancy work, as well as supporting commercial activities to secure the growth of CP&C Regulatory and where possible, testing work, in global locations.

B. People Responsibilities :

None, but whilst there are no line management responsibilities anticipated for this position, the Expert Consultant is actively involved in role selection and recruitment, coaching or mentoring of other staff members and proactive networking to further develop the APAC CP&C business.

C. Essential Job Duties: 

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

• JMAFF Regulatory and scientific advice to customers (consulting and testing)

  • 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.

• Study Summaries/Dossier Preparation

  • 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.

• Proposal generation

  • Scope out work required and prepare a proposal including cost build activities with the aid of planning and business staff.

• Mentoring

  • 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.

• Industry profile

  • 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.

• Authority Contact

  • 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%).

• Departmental Activities:

  • Responsible for pro-actively suggesting process improvements to systems, processes and infrastructure within CP&C Regulatory, to ensure effective and efficient performance (5%).     

Travel Requirements:    ___ X ____  Yes  _______No

______ Local

______ Domestic

__ X __ Regional

______ Global

% of time: 10%

% of the above that requires overnight stay: 90%

Travel is primarily to where: Europe

Language Skills Required:

Japanese & English

• Speaking:             ___X__Yes   _____No    

• Writing/Reading:  __ X__Yes  ______No    

Experience:

Minimum Required:

• Significant (>10 years’) experience in toxicology within the regulatory testing or consultancy sectors.

• An industry profile, with established relationships with relevant contacts within Regulatory Authorities and CP&C customers – especially in Japan and with JMAFF

Education :

Recommended:

BSc/PhD (relevant experience which may be substituted for level of education)

Working Conditions:

Role is primarily office-based (remote working), along with travel for customer and regulatory authority meetings and conferences . 

Special Factors:

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.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. 

We encourage all to apply

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