MMV Severe Malaria Consortium –vacancy,Job from Medicines for Malaria Venture,UGANDA
Post:MMV Severe Malaria Consortium –
Intrarectal Astesunate (lr AS) prequalification Project Manager
Job
from Medicines for Malaria VentureThis is a consultancy position, not an MMV staff position.
Medicines for Malaria Venture (MMV) was established in 1999 as a partnership between the public and
private sector to discover, develop and deliver new antimalarial drugs at prices affordable to developing countries.
MMV
and its consortium partners have been awarded a three-year grant by
UNITAID for the implementation of a project entitled “Improving Severe
Malaria Outcomes”, with the objective of securing the prequalification
pathway for prequalification of Ir AS along with the development of a
GMP commercial-scale manufacturing solution.
MMV is seeking a
contract Project Manager for this three-year project. This position will
work closely with potential manufacturers of Ir AS and WHO
prequalification to ensure the goals, outputs and activities of the
project are being achieved within the planned timelines. This will
involve travel between the manufacturer(s) to achieve these goals. This
position will report to MMV’s Head of Translational Medicine.
We
are seeking a highly motivated individual with outstanding credentials,
analytical ability, and communication skills. The candidate must be able
to function independently and should have a proven track record of
excellence in pharmaceutical project management.
The Project Manager will:
- Provide analytical and technical support to MMV in ensuring
prequalification of at least one manufacturer of artesunate
suppositories.
- On behalf of MMV, monitor timely progress and completion of key deliverables.
- Manage the dossier transfer from WHO TDR and review existing
Phase III clinical data and manufacturing master files. Identify
industrial partner(s) for Ir AS manufacturing solution.
- Guide industrial partner(s) in conducting the Stability Testing
of intrarectal artesunate formulations to ensure that the product will
meet the TPP.
- Provide technical assistance to industrial partner(s) to prepare
for WHO PQ GMP inspection. Provide assistance to industrial partner(s)
in preparation and during the submission of PQ dossier.
- Plan and execute with industrial partner(s) the clinical studies
required by WHO PQ to establish relative bioavailability of a rectal
formulation of artesunate.
- Manage the budget allocated to the project.
- Assist the MMV Finance and Access Teams in developing bi-annual
reports for the donor, including progress against log frame targets.
- Disseminate information from MMV and partners at Advisory group meetings.
Essential qualifications and skills:
- Life science degree
- 5-7 years of relevant work experience in the field or in pharmaceutical /healthcare industry
- Excellent written and oral communication skills
- Strong report-writing skills, particularly with regards to donor reporting requirements
- Strong problem solving skills and analytical capabilities
- Detail-oriented with strong organization skills
- Ability to handle multiple tasks simultaneously, set priorities, and work independently
- Ability to be effective in high-pressure situations and work in a fast-paced, limited-structure, -multicultural environment
Added Assets:
- Experience in management of pharmaceutical industry development projects
- Experience in interaction with regulatory agencies and/or WHO prequalification
- Planning and execution of bioequivalence/relative bioavailability studies
For more information about MMV’s activities please refer to our website www.mmv.org.
How to apply:Interested
applicants should send their CV and a covering letter giving reasons
for their interest in the position to jobs@mmv.org before 10 June 2013.
Please refer to the following code in the subject line of your email:
A&PM-2013-4
For more information about MMV’s activities please refer to our website www.mmv.org.
Job ID: #577434
Closing date: 10 Jun 2013
http://reliefweb.int/job/577434/mmv-severe-malaria-consortium-%E2%80%93-intrarectal-astesunate-lr-prequalification-project
http://reliefweb.int/job/577434/mmv-severe-malaria-consortium-%E2%80%93-intrarectal-astesunate-lr-prequalification-project