position in an exciting company.
* Together with the Head of Sceintific Affairs and in collaboration
with the Regulatory Affairs Manager, actively plan the Veterinary
Clinical function requirements ensuring major milestone targets for
each product are visible to all team members and key stakeholders to
achieve on time market entry.
* Together with the Head of Scientific Affairs and in collaboration
with the Regulatory Affairs Manager, determine tasks and resources
required to deliver each project milestone and deliverable.
* 2. Clinical Studies
* Design and manage all clinical trials associated with the
Veterinary projects including target animal safety and efficacy
studies in collaboration with external experts and Clinical Research
Organisations.
* Identify and manage external resources required to ensure
completion of the necessary studies to achieve the target milestones.
Travel to clinical sites may be required to ensure Sponsor oversight
of the studies.
* In collaboration with the Regulatory Affairs Manager, manage the
preparation of relevant dossier sections to support Veterinary license
applications including the relevant sections of Modules 2, 4 and 5.
* Managing a small team of clinical experts to support the
Veterinary portfolio development.
* Coaching/mentoring - support members of team with problem solving
and skills development to aid learning and early problem resolution
* Manage applicable clinical affairs budget and cost centre
activities required for veterinary clinical activities.
* Veterinary Business Strategy
* -Together with the Business Development Manager and relevant
technical experts, support existing veterinary partnerships with
external partners as well as working to identify new development
opportunities for the development of veterinary medicines.
* Bachelor of Veterinary Medicine
* Significant clinical practice experience in companion animal
space, ideally to include clinical research and in a cGxP environment.
* Familiarity with cGxP in pharmaceutical manufacturing
* Familiarity with concepts of Regulatory Approval process for
veterinary pharmaceutical products
* Technical knowledge of clinical research in the Veterinary space,
with emphasis on small animal practice
* Multi-tasking- ability to manage conflicting deadlines
* Good planning and organizational skills
* Working knowledge of EDMS (Electronic Document Management System)
* Planning and organising - effectively develop and implement plans
to accomplish project objectives.
* Communication - write, speak and present information effectively
across communication settings.
* Adaptability - maintain effectiveness in varying environments and
with different tasks, responsibilities and people.
* Problem Solving/Analysis - secure relevant information and
identify key issues and relationships from a base of information;
relate and compare data from different sources, identifying
cause-effect relationships.
* Teamwork and Collaboration - working effectively with team _I_
work group or those outside the formal line of authority (e.g. peers,
senior managers) to accomplish organisational goals; taking actions
that respect the needs and contributions of others, contributing to
and accepting the consensus; subordinating own objectives to the
objectives of the organisation.
* Initiative - making attempts to influence events to achieve goals;
self -starting rather than accepting passively; taking action to
achieve goals beyond what is required; being proactive.
* Ability to understand complex clinical terminology and aptitude to
learn new skills in the area of clinical research though working with
external experts and CROs.
We&#**Apply on the website**;re looking for a candidate to this
position in an exciting company.
* Together with the Head of Sceintific Affairs and in collaboration
with the Regulatory Affairs Manager, actively plan the Veterinary
Clinical function requirements ensuring major milestone targets for
each product are visible to all team members and key stakeholders to
achieve on time market entry.
* Together with the Head of Scientific Affairs and in collaboration
with the Regulatory Affairs Manager, determine tasks and resources
required to deliver each project milestone and deliverable.
* 2. Clinical Studies
* Design and manage all clinical trials associated with the
Veterinary projects including target animal safety and efficacy
studies in collaboration with external experts and Clinical Research
Organisations.
* Identify and manage external resources required to ensure
completion of the necessary studies to achieve the target milestones.
Travel to clinical sites may be required to ensure Sponsor oversight
of the studies.
* In collaboration with the Regulatory Affairs Manager, manage the
preparation of relevant dossier sections to support Veterinary license
applications including the relevant sections of Modules 2, 4 and 5.
* Managing a small team of clinical experts to support the
Veterinary portfolio development.
* Coaching/mentoring - support members of team with problem solving
and skills development to aid learning and early problem resolution
* Manage applicable clinical affairs budget and cost centre
activities required for veterinary clinical activities.
* Veterinary Business Strategy
* -Together with the Business Development Manager and relevant
technical experts, support existing veterinary partnerships with
external partners as well as working to identify new development
opportunities for the development of veterinary medicines.
* Bachelor of Veterinary Medicine
* Significant clinical practice experience in companion animal
space, ideally to include clinical research and in a cGxP environment.
* Familiarity with cGxP in pharmaceutical manufacturing
* Familiarity with concepts of Regulatory Approval process for
veterinary pharmaceutical products
* Technical knowledge of clinical research in the Veterinary space,
with emphasis on small animal practice
* Multi-tasking- ability to manage conflicting deadlines
* Good planning and organizational skills
* Working knowledge of EDMS (Electronic Document Management System)
* Planning and organising - effectively develop and implement plans
to accomplish project objectives.
* Communication - write, speak and present information effectively
across communication settings.
* Adaptability - maintain effectiveness in varying environments and
with different tasks, responsibilities and people.
* Problem Solving/Analysis - secure relevant information and
identify key issues and relationships from a base of information;
relate and compare data from different sources, identifying
cause-effect relationships.
* Teamwork and Collaboration - working effectively with team _I_
work group or those outside the formal line of authority (e.g. peers,
senior managers) to accomplish organisational goals; taking actions
that respect the needs and contributions of others, contributing to
and accepting the consensus; subordinating own objectives to the
objectives of the organisation.
* Initiative - making attempts to influence events to achieve goals;
self -starting rather than accepting passively; taking action to
achieve goals beyond what is required; being proactive.
* Ability to understand complex clinical terminology and aptitude to
learn new skills in the area of clinical research though working with
external experts and CROs.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
