Trial Supplies Manager
- Location: Lawrenceville
- Job Type:Contract
Posted 23 days ago
- Expiry Date: 02 June 2022
- Referral: 206056@accuick.com
About Client:
Bristol Myers Squibb manufactures prescription pharmaceuticals and biologics in several therapeutic areas.
Job Description:
This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.
Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.
Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.
Developing supply forecasts through evaluation of the clinical development plan and protocol analysis.
Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create packaging
specifications in collaboration with Clinical Operations partners.
Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for
investigational product to meet all protocol and regulatory requirements.
Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand.
Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team.
Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.
Required:
Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
Proficient and strong analytical skills.
Strong communication and negotiation skills.
Proficient and strong Project management skills.
Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.
Proficient knowledge of import / export requirements.
Proficient/Strong knowledge of IRT and CTMS systems.
Ideal Candidates Would Also Have:
Coaching and mentoring (fosters teamwork).
Other Qualifications:
Bachelor’s degree required.
2 years of relevant work experience required, preferably in a pharmaceutical environment.
An equivalent combination of education and experience may substitute.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.